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GLP-1 Clinical Trial Demographics: 17 Trials, 21,063 Adults

Last verified: August 1, 2026 · Dataset version 1.0 · Next scheduled review: September 1, 2026 By The RX Index Editorial Team — The RX Index Research An independent research and reference resource. Educational content, not medical advice.


Across the 17 adult weight-management efficacy trials described in the current U.S. prescribing information for every FDA-approved GLP-1–based weight-management medicine — Saxenda, Wegovy, Zepbound and Foundayo — the label-reported baseline cohorts total 21,063 participants. Using participant-weighted calculations from the labels' rounded figures, that population had a mean age of 47.9 years and was 67.0% female, 73.7% White and 9.1% Black or African American. We verified every row against the current labels on August 1, 2026.

Here is the number that requires reading across all four labels. Section 8.5 identifies 91 drug-treated participants aged 75 or older across the five weight-management treatment populations the labels report separately: Saxenda 17, Wegovy injection 23, Wegovy tablets 5, Zepbound 13 and Foundayo 33. Not 91 percent. Ninety-one people. This is not a count across all 21,063 randomized participants: Section 8.5 uses separate drug-treated safety or treatment denominators, and Zepbound's count covers only fixed-dose Studies 1 and 2.

That gap sits alongside a second one the labels make visible only if you read across products: trials excluding type 2 diabetes were 72.5% female, while trials enrolling adults with type 2 diabetes were 49.5% female. Same drug class, same era, two very different rooms.

What do GLP-1 clinical trial demographics show at a glance?

Answer capsule: The 17 qualifying adult weight-management trial cohorts total 21,063 participants. Participant-weighted estimates are 47.9 years for mean age, 67.0% female, 73.7% White and 9.1% Black or African American; Asian and Hispanic/Latino estimates use smaller field-specific denominators because the labels do not report every field in every trial.

Table 1. GLP-1 clinical trial demographics — adult weight-management trials in current U.S. labels, verified August 1, 2026
MeasureFindingField denominator
Qualifying trials1717 trials
Label-reported baseline participants21,06317 trials
Participant-weighted mean age47.9 yearsN = 21,063
Reported as female67.0%N = 21,063
White73.7%N = 21,063
Black or African American9.1%N = 21,063
Asian15.9%N = 16,275 (14 trials)
Hispanic or Latino ethnicity25.2%N = 20,662 (16 trials)
American Indian or Alaska NativeNot pooledReported in only 3 trials (N = 7,279)
Drug-treated participants aged 75+ reported in Section 8.591 (count)5 label-reported treatment populations; not denominator-compatible with the 17-trial census

Source: Current U.S. prescribing information for Saxenda, revised February 2026, Wegovy, revised June 2026, Zepbound, revised February 2026 and Foundayo, revised April 2026. Participant-weighted calculations by The RX Index Research. Label percentages are rounded, so pooled values are approximate.

Race and Hispanic or Latino ethnicity are separate fields in FDA labeling. They overlap and must never be added together. A participant counted as White may also be counted as Hispanic or Latino.

What is included in this dataset, and what does "GLP-1" mean here?

Answer capsule: This is a census of the adult weight-reduction and long-term weight-maintenance efficacy trials described in the current U.S. labels for the four FDA-approved weight-management medicines whose mechanism includes GLP-1 receptor agonism as of August 1, 2026. It covers Saxenda (liraglutide), Wegovy (semaglutide injection and tablets), Zepbound (tirzepatide) and Foundayo (orforglipron), while excluding pediatric studies, diabetes-only product labels and trials presented under cardiovascular, MASH or obstructive sleep apnea indications.

Two definitions matter before the numbers make sense.

A GLP-1 receptor agonist activates the glucagon-like peptide-1 receptor. The current labels describe delayed gastric emptying as part of the pharmacology of these medicines. Tirzepatide — the molecule in Zepbound — is not a GLP-1-only agonist. Its label identifies it as a glucose-dependent insulinotropic polypeptide (GIP) receptor and GLP-1 receptor agonist. We include it because "GLP-1" is the working umbrella term used for this field, but we name the dual mechanism wherever precision matters.

We chose the current-label boundary on purpose. It is reproducible: anyone can open the same four PDFs, apply the same rule and recover the same 17 trials. A broader rule — "every GLP-1 obesity trial ever run" — would require judgment calls about pipeline compounds, unpublished studies, discontinued programs and superseded evidence.

Table 2. What this census excludes
ExcludedReason
Pediatric trialsThis is an adult census. Pediatric eligibility, age distribution and reporting conventions differ enough that pooling them would be misleading.
Ozempic, Rybelsus and Mounjaro trialsThese are diabetes product labels. The same molecules appear here only where they are presented in the qualifying Wegovy or Zepbound weight-management sections.
SELECTPresented under Wegovy's cardiovascular risk-reduction section, not its weight-management efficacy section. Its older-adult data are used separately below and labeled as context.
Zepbound Studies 5 and 6Presented under the obstructive sleep apnea indication.
Wegovy MASH trialPresented under the MASH indication.
Retatrutide and other pipeline moleculesNot FDA approved within the dataset cutoff.

Source: Sections 1 and 14 of the four current U.S. prescribing-information documents linked above. Scope decision and exclusion coding by The RX Index Research.

How many older adults were in the GLP-1 weight-loss trials?

Answer capsule: The current labels' Geriatric Use sections report 91 drug-treated participants aged 75 or older across five separately described weight-management treatment populations. Each label-reported share falls between 0.5% and 2%, but these counts do not use the same denominator as the 17 randomized trial cohorts and must not be turned into one pooled percentage.

Table 3. Older-adult participation reported in Section 8.5 of current weight-management labels
Label-reported treatment populationAged 65+Aged 75+Age-reporting conventionLabel source
Saxenda adult clinical trials232 (6.9%)17 (0.5%)Nested — age 75+ is included in age 65+§8.5, PDF viewer p. 15
Wegovy injection weight-reduction and maintenance trials256 (about 10%, derived)23 (1%)Additive — 233 (9%) aged 65 to <75 plus 23 (1%) aged 75+§8.5, PDF viewer p. 21
Wegovy tablets weight-reduction and maintenance trial21 (about 10%, derived)5 (2%)Additive — 16 (8%) aged 65 to <75 plus 5 (2%) aged 75+§8.5, PDF viewer p. 21
Zepbound fixed-dose Studies 1 and 2226 (9%)13 (0.5%)Nested; this count does not include Zepbound Studies 3 and 4§8.5, PDF viewer p. 11
Foundayo-treated participants in pooled Trials 1 and 2399 (13%)33 (1%)Nested§8.5, PDF viewer p. 11

Source: Section 8.5 of the current Saxenda, Wegovy, Zepbound and Foundayo labels. Derived Wegovy counts add non-overlapping strata; derived percentages remain approximate because the label percentages are rounded. Verified August 1, 2026.

Twelve years. Two manufacturers. Injections and tablets. Peptide medicines and a non-peptide small molecule. The reported share aged 75 or older never exceeded 2%, and in four of the five treatment populations it sat at or below 1%.

The age-reporting trap

The labels do not use the same age strata.

Saxenda, Zepbound and Foundayo report "65 years of age or older" and "75 years of age or older" as nested categories. The second is a subset of the first. Wegovy's weight-management paragraphs report "65 to less than 75 years" and "75 years and older" as separate, additive categories.

That means Wegovy injection's exact reported count aged 65 or older is 256 — 233 plus 23 — and the tablets count is 21 — 16 plus 5. Their approximate shares are 10% after adding the labels' rounded 9% + 1% and 8% + 2%.

The current Wegovy label then switches wording in its cardiovascular paragraph, reporting people "aged 65 to 75 years" and people "aged 75 years and older." Those categories overlap at age 75 as written. We do not add them.

How the same Wegovy label reports older adults in other indications

Table 4. Older-adult reporting by indication in the current Wegovy label
Wegovy programIndicationFirst age band as written in the labelAged 75+Can the two bands be added?
Injection weight-management trialsWeight reduction and long-term maintenance233 (9%) aged 65 to <7523 (1%)Yes — the bands do not overlap
SELECTCardiovascular risk reduction2,656 (30%) aged 65 to 75703 (8%)No — age 75 appears in both bands as written
MASH trialMASH138 of 534 (26%) aged 65+13 (2%)No — age 75+ is nested inside age 65+

Source: Section 8.5 of the current Wegovy U.S. Prescribing Information, revised June 2026. Verified August 1, 2026.

The aged-75-and-older share was 1% in the injection weight-management treatment population and 8% in SELECT. Same molecule, same label, different indication and trial population. The labels show the enrollment difference; they do not establish why it occurred.

Foundayo's sponsor has published a post-hoc age analysis

In a May 22, 2026 announcement tied to the European Congress on Obesity, Lilly reported an exploratory post-hoc analysis of ATTAIN-1 and ATTAIN-2. The full randomized populations included 195 participants aged 65 or older in ATTAIN-1 and 418 in ATTAIN-2; those counts include placebo participants, which is why they do not equal the Foundayo-treated count of 399 in Table 3.

At the highest approved dose, Lilly reported mean body-weight reductions of 13.0% among participants aged 65 or older in ATTAIN-1 and 12.2% in ATTAIN-2. In the pooled safety analysis, serious adverse events were reported by 9.9%, 13.0% and 11.6% of participants aged 65 or older across the 5.5 mg, 9 mg and 17.2 mg groups, compared with 5.6%, 6.2% and 5.4% among participants younger than 65; the placebo rates were 11.4% and 5.4%, respectively.

Lilly identifies the analysis as post hoc, exploratory, not prespecified and hypothesis-generating. That limitation belongs next to the result, not in fine print.

Source: Eli Lilly and Company, May 22, 2026: post-hoc ATTAIN-1/2 analysis in adults aged 65 and older. This is sponsor-reported secondary analysis, not a prespecified trial endpoint.

What does this dataset show — and what does it not show?

Answer capsule: This dataset shows who appeared in the demographic populations summarized by current FDA labeling for adult GLP-1 weight-management trials, how completely each field was reported and how composition differs across products and diabetes-status groups. It does not measure real-world use, prove that any group was underrepresented against a benchmark, or establish that the medicines work differently by age, sex, race or ethnicity.

Table 5. Scope of inference
What this dataset supportsWhat it does not support
Statements about who was in the label-reported trial cohortsStatements about who currently takes these medicines
Comparisons of demographic composition across products and trialsClaims that a demographic difference caused a difference in results
Statements about which fields the labels report and which they omitFilling omitted fields with zero or outside estimates
Descriptive comparison of trials with and without type 2 diabetesCausal explanations for why enrollment differed
A count of participants in a label-reported age bandA pooled percentage across incompatible safety and randomized denominators
Identifying that a representation question needs a stated benchmarkA benchmark-free verdict that the trials were or were not representative

Source: Inference rules defined in the published methodology below. The distinctions follow directly from the four labels' cohort definitions, missing fields and incompatible denominators.

Trial enrollment and real-world use are different populations produced by different processes. Trial participants are recruited, screened against eligibility criteria and supported with monitoring and study visits that routine care does not provide.

How was this GLP-1 clinical trial demographics dataset built?

Answer capsule: We read the current U.S. prescribing information for all four in-scope medicines, extracted every adult efficacy trial presented in the weight-reduction and long-term weight-maintenance sections, recorded each demographic field exactly as reported, preserved missing fields as missing and calculated participant-weighted results independently for each field. We separately extracted Section 8.5 age counts because those paragraphs use treatment or safety populations that cannot be merged into the 17-trial denominator.

Inclusion algorithm

  1. Identify every FDA-approved weight-management medicine whose mechanism includes GLP-1 receptor agonism as of the verification date.
  2. Retrieve the current U.S. prescribing information for each medicine.
  3. Extract every adult trial presented under the weight-reduction or long-term weight-maintenance clinical-study sections.
  4. Exclude pediatric studies, diabetes-only product labels and trials presented exclusively under cardiovascular, MASH or obstructive sleep apnea indications.
  5. Record the demographic cohort exactly as the label defines it.
  6. Cross-check each trial against its ClinicalTrials.gov identifier.
  7. Extract Section 8.5 age counts into a separate table rather than blending them with the randomized-cohort census.

The denominator rule

Where a trial used a run-in or lead-in period, the denominator follows the population the label's demographic paragraph actually describes. Wegovy Study 5 uses the 803 randomized participants, not the 902 who entered the 20-week active-drug run-in. Zepbound Studies 3 and 4 use the 579 and 670 randomized populations, not the 806 and 783 who began their lead-in periods.

Using the pre-randomization counts in those three trials would add 439 people to the census: 99 in Wegovy Study 5, 227 in Zepbound Study 3 and 113 in Zepbound Study 4. Saxenda Study 3 also used a responder-selection run-in, but the current label does not report a larger run-in entrant count in the demographic paragraph, so we do not invent one.

The calculation

Weighted result = Σ(trial N × trial percentage) ÷ Σ(trial N)

A trial enters a field's denominator only when that field is reported or can be derived without ambiguity. Wegovy Study 6 states that all participants were Asian, which permits White and Black shares of 0% to be derived; we did that and flagged it. An omitted Asian or ethnicity field is recorded as not reported, never as zero.

The labels usually report rounded whole-number percentages. Every pooled figure on this page is therefore an approximation of the underlying data, presented to one decimal place. It is not a reconstruction of individual-level results.

Source-version map

Table 6. Label versions and clinical-study locations used
ProductCurrent label usedClinical-study sectionPDF viewer pages containing the included demographic paragraphsQualifying trials
SaxendaRevised February 2026§14.119–203
WegovyRevised June 2026§14.229–318
ZepboundRevised February 2026§14.115, 22 and 254
FoundayoRevised April 2026§14152

Primary sources: Saxenda U.S. Prescribing Information · Wegovy U.S. Prescribing Information · Zepbound U.S. Prescribing Information · Foundayo U.S. Prescribing Information. Verified August 1, 2026.

Which trials are in the census, and what did each report?

Answer capsule: The census contains 3 Saxenda trials, 8 Wegovy trials — including oral Wegovy and the 7.2 mg dose — 4 Zepbound weight-management trials and 2 Foundayo trials. Every row below carries its ClinicalTrials.gov identifier, diabetes status, demographic denominator, source location and any design feature that selected the population before randomization.

NR = not separately reported in the relevant label demographic paragraph. AI/AN = American Indian or Alaska Native. Race and Hispanic/Latino ethnicity are separate dimensions.

Saxenda (liraglutide)

Table 7. Saxenda weight-management trial demographics
FDA study / programRegistryT2DNMean ageFemaleWhiteBlackAsianAI/ANHispanic/LatinoDesign noteLabel source
Study 1 / SCALE Obesity & PrediabetesNCT01272219Excluded3,7314579%85%10%NRNR11%Conventional randomized trial§14.1, PDF p. 19
Study 2 / SCALE DiabetesNCT01272232Included6355550%83%12%NRNR10%Adults with type 2 diabetes§14.1, PDF p. 20
Study 3 / SCALE MaintenanceNCT00781937Excluded4224681%84%13%NRNR7%Only participants losing ≥5% during a 4–12-week diet run-in were randomized§14.1, PDF p. 20

Source: Saxenda U.S. Prescribing Information, revised February 2026. Trial identifiers cross-checked against ClinicalTrials.gov. Verified August 1, 2026.

The three Saxenda demographic paragraphs do not separately report Asian participation. That is why Saxenda's 4,788 participants sit outside the Asian denominator throughout this page.

Wegovy (semaglutide injection and tablets)

Table 8. Wegovy weight-management trial demographics
FDA study / programRegistryT2DNMean ageFemaleWhiteBlackAsianAI/ANHispanic/LatinoDesign noteLabel source
Study 2 / STEP 1NCT03548935Excluded1,9614674%75%6%13%NR12%Wegovy injection 2.4 mg§14.2, PDF p. 30
Study 3 / STEP 2NCT03552757Included8075551%62%8%26%NR13%Adults with type 2 diabetes§14.2, PDF p. 30
Study 4 / STEP 3NCT03611582Excluded6114681%76%19%2%NR20%Intensive behavioral therapy during the trial§14.2, PDF p. 30
Study 5 / STEP 4NCT03548987Excluded8034679%84%13%2%NR8%Randomized after a 20-week Wegovy run-in; 902 entered and 803 were randomized§14.2, PDF p. 30
Study 6 / STEP 6NCT03811574Mixed (24.7% T2D)4015137%0%\*0%\*100%NRNRConducted in Japan and South Korea§14.2, PDF pp. 30–31
Study 7 / OASIS 4NCT05564117Excluded3074879%92%7%1%NR7.8%Oral Wegovy 25 mg§14.2, PDF p. 31
Study 8 / STEP UPNCT05646706Excluded1,4074774%86%9%4%NR5%Wegovy 7.2 mg, 2.4 mg or placebo§14.2, PDF p. 31
Study 9 / STEP UP T2DNCT05649137Included5125652%84%9%6%NR6%Wegovy 7.2 mg in adults with type 2 diabetes§14.2, PDF p. 31

\Derived from the label's statement that all participants were Asian.*

Source: Wegovy U.S. Prescribing Information, revised June 2026. Trial identifiers cross-checked against ClinicalTrials.gov. Verified August 1, 2026.

Zepbound (tirzepatide — GIP and GLP-1 receptor agonist)

Table 9. Zepbound weight-management trial demographics
FDA study / programRegistryT2DNMean ageFemaleWhiteBlackAsianAI/ANHispanic/LatinoDesign noteLabel source
Study 1 / SURMOUNT-1NCT04184622Excluded2,5394568%71%8%11%9%48%Fixed-dose weight-reduction trial§14.1, PDF p. 15
Study 2 / SURMOUNT-2NCT04657003Included9385451%76%8%13%NR60%Adults with type 2 diabetes§14.1, PDF p. 15
Study 3 / SURMOUNT-3NCT04657016Excluded5794663%86%11%1%NR54%Only participants losing ≥5% during a 12-week lifestyle lead-in were randomized; 806 initially enrolled§14.1, PDF p. 22
Study 4 / SURMOUNT-4NCT04660643Excluded6704971%80%11%7%NR44%Randomized after a 36-week open-label lead-in; 783 entered and 670 were randomized§14.1, PDF p. 25

Source: Zepbound U.S. Prescribing Information, revised February 2026. Trial identifiers cross-checked against ClinicalTrials.gov. Verified August 1, 2026.

Foundayo (orforglipron)

Table 10. Foundayo weight-management trial demographics
FDA trial / programRegistryT2DNMean ageFemaleWhiteBlackAsianAI/ANHispanic/LatinoDesign noteLabel source
Trial 1 / ATTAIN-1NCT05869903Excluded3,1274564%56%9%28%0.4%38%72-week trial§14, PDF p. 15
Trial 2 / ATTAIN-2NCT05872620Included1,6135747%71%7%17%0.3%30%72-week trial in adults with type 2 diabetes§14, PDF p. 15

Source: Foundayo U.S. Prescribing Information, revised April 2026. Trial identifiers cross-checked against ClinicalTrials.gov. Verified August 1, 2026.

The Foundayo label states that effectiveness was established in trials of an investigational orforglipron formulation and that Section 14 presents those efficacy data as equivalent once-daily Foundayo dosages. We keep that qualification attached because it changes how directly the trials map to the marketed tablets.

Product-level totals

Table 11. Participant-weighted demographics by product
ProductTrialsNMean ageFemaleWhiteBlackAsianHispanic/Latino
Saxenda34,78846.475.3%84.6%10.5%NR10.5%
Wegovy86,80948.468.9%73.9%8.8%14.5%10.2%\*
Zepbound44,72647.564.4%75.1%8.8%9.6%50.5%
Foundayo24,74049.158.2%61.1%8.3%24.3%35.3%

\Wegovy's Hispanic/Latino estimate uses N = 6,408 because Study 6 did not report ethnicity.*

Source: The four current U.S. labels; participant-weighted calculations by The RX Index Research. Verified August 1, 2026.

These are not drug effects. A product's row describes the population assembled for its trial program. The programs differed in geography, eligibility, diabetes status, design, dose and era.

What percentage of GLP-1 trial participants were female, and how old were they?

Answer capsule: Across all 17 trials, 67.0% of participants were reported as female and the participant-weighted mean age was 47.9 years. Trial-level female participation ranged from 37% to 81%, while reported mean age ranged from 45 to 57 years.

The spread is wide enough that a single headline percentage hides most of the story.

  • Lowest female share (37%): Wegovy Study 6 / STEP 6, conducted in Japan and South Korea, where 24.7% of participants had type 2 diabetes.
  • Highest female share (81%): Saxenda Study 3 / SCALE Maintenance and Wegovy Study 4 / STEP 3; both excluded type 2 diabetes.
  • Youngest cohorts (mean age 45): Saxenda Study 1, Zepbound Study 1 and Foundayo Trial 1; all excluded type 2 diabetes.
  • Oldest cohort (mean age 57): Foundayo Trial 2 / ATTAIN-2, which enrolled adults with type 2 diabetes.

One definitional note: the labels report participants as female or male. They do not report gender identity, and this dataset should not be described as reporting it.

Source: Trial-level values in Tables 7–10 and the participant-weighted calculation described above.

How did trial demographics differ with and without type 2 diabetes?

Answer capsule: Trials excluding type 2 diabetes were younger and more heavily female than trials enrolling adults with type 2 diabetes — 45.7 years and 72.5% female versus 55.6 years and 49.5% female. This is a descriptive comparison among dissimilar trials, not a causal finding.

Table 12. Demographics by type 2 diabetes status
Trial populationTrialsNMean ageFemaleWhiteBlackAsianHispanic/Latino
Type 2 diabetes excluded1116,15745.772.5%75.6%9.5%12.9%†24.6%
Type 2 diabetes included54,50555.649.5%73.6%8.3%16.5%‡27.7%
Mixed population (STEP 6)140151.037.0%0%\*0%\*100%NR

†Asian denominator N = 12,004 across nine reporting trials. ‡Asian denominator N = 3,870 across four reporting trials. \Derived from the label's statement that all 401 participants were Asian; 24.7% had type 2 diabetes.*

Source: The four current U.S. labels; trial classification and participant-weighted calculations by The RX Index Research. Verified August 1, 2026.

The overall female majority is concentrated in the trials that excluded type 2 diabetes. The diabetes trials were close to sex-balanced.

The White and Black shares moved much less: 75.6% versus 73.6% White and 9.5% versus 8.3% Black or African American. We are not going to tell you why the age and sex distributions differed. This dataset cannot establish that.

What it can establish is narrower and useful: anyone quoting "GLP-1 weight-management trials were roughly two-thirds female" should know that the figure blends two populations with very different sex and age distributions.

What were the racial and ethnic demographics of the trials?

Answer capsule: Participant-weighted estimates were 73.7% White and 9.1% Black or African American across all 17 trials. Asian participation was 15.9% among the 14 trials reporting or permitting derivation of that field, and Hispanic or Latino ethnicity was 25.2% among the 16 trials reporting ethnicity; missing fields remain missing.

Before the numbers, the reporting quality — because it constrains what any of them mean.

Table 13. Reporting completeness across the 17 trials
FieldTrials with a usable valueParticipants in denominator
Mean age17 of 1721,063
Female share17 of 1721,063
White17 of 17\*21,063
Black or African American17 of 17\*21,063
Asian14 of 1716,275
Hispanic or Latino ethnicity16 of 1720,662
American Indian or Alaska Native3 of 177,279

\Includes a derived 0% for Wegovy Study 6, where the label states all participants were Asian.*

Source: Current U.S. prescribing information for Saxenda, Wegovy, Zepbound and Foundayo. Reporting-completeness audit by The RX Index Research. Verified August 1, 2026.

American Indian or Alaska Native participation is explicitly reported in three of seventeen trials: Zepbound Study 1 at 9%, Foundayo Trial 1 at 0.4% and Foundayo Trial 2 at 0.3%. We do not publish a pooled figure for that field because a weighted average across three selectively reporting trials would look more complete than the source data are.

That absence is itself a finding. The current labels do not tell a reader the American Indian or Alaska Native participation rate for fourteen of the seventeen trial cohorts.

Why does the Hispanic/Latino figure swing from 10% to 51%?

Answer capsule: The participant-weighted Hispanic or Latino share ranges from 10.2% in the Wegovy program to 50.5% in the Zepbound program. The current labels report full trial-population totals and do not provide a U.S.-only demographic subset for these weight-management cohorts, so those percentages cannot be read as U.S.-only representation or used by themselves to explain why programs differ.

Table 14. Selected cross-program reporting ranges
FieldLowest reported valueHighest reported valueComparison level
Hispanic or Latino10.2% (Wegovy)50.5% (Zepbound)Product-program aggregate
American Indian or Alaska Native0.3% (Foundayo ATTAIN-2)9% (Zepbound SURMOUNT-1)Trial-level values; only 3 trials report the field
Asian9.6% (Zepbound)24.3% (Foundayo)Product-program aggregate among products with reported values
White61.1% (Foundayo)84.6% (Saxenda)Product-program aggregate; 23.5-point spread

Source: Product-level participant-weighted values in Table 11 and trial-level values in Tables 9–10. Verified August 1, 2026.

The labels do not provide enough information to separate the effects of trial geography, site selection, eligibility criteria, recruitment and other design choices. The honest sentence is not "Zepbound's trials were 50.5% Hispanic in America." It is:

The Zepbound weight-management trials reported 50.5% Hispanic or Latino ethnicity across their full participant populations; the current label does not disclose a U.S.-only demographic subset.

That distinction is the difference between a citable sentence and a wrong one.

Did run-in periods materially change the pooled findings?

Answer capsule: Four trials reported demographics for populations selected after a diet, lifestyle or active-drug lead-in. Removing those 2,474 randomized participants — 11.7% of the census — shifts the headline values by 1.8 percentage points or less, so the principal findings are not being created by the pre-selected cohorts.

Four trials did not randomize everyone who entered the preceding phase:

  • Saxenda Study 3: only participants losing at least 5% during a low-calorie-diet run-in were randomized. The current label does not state the larger run-in entrant count in the demographic paragraph.
  • Wegovy Study 5 / STEP 4: 902 entered the 20-week active-drug run-in; 803 were randomized.
  • Zepbound Study 3 / SURMOUNT-3: 806 initially enrolled; 579 participants who lost at least 5% during the 12-week lifestyle lead-in were randomized.
  • Zepbound Study 4 / SURMOUNT-4: 783 entered the 36-week open-label Zepbound lead-in; 670 were randomized.

Those four randomized populations total 2,474 participants. We ran the census with and without them.

Table 15. Sensitivity analysis — full census versus run-in-selected trials removed
MetricAll 17 trialsExcluding 4 run-in-selected trialsChange
Trials1713−4
Participants21,06318,589−2,474
Mean age47.948.0+0.1
Female67.0%66.1%−0.9 pts
White73.7%72.5%−1.2 pts
Black or African American9.1%8.7%−0.4 pts
Asian (reporting trials)15.9%17.7%+1.8 pts
Hispanic/Latino (reporting trials)25.2%24.8%−0.4 pts

Source: The four current U.S. labels; participant-weighted calculations by The RX Index Research. Verified August 1, 2026.

Nothing moves much. The largest change is 1.8 percentage points in the Asian field. The point is not that the result is dramatic. The point is that it is checkable, and that the 67.0% female estimate survives a reasonable sensitivity test.

Were the GLP-1 clinical trial populations representative?

Answer capsule: This dataset cannot produce a defensible yes-or-no answer, and we are not going to manufacture one. Representation is a comparison that requires a stated benchmark — such as U.S. adults, U.S. adults with obesity, a global obesity population or people eligible for a specific indication — and those choices can produce different answers.

A U.S. Census benchmark answers a different question from a multinational disease-population benchmark. Comparing trial participation with all U.S. adults also differs from comparing it with U.S. adults who have obesity.

The National Center for Health Statistics estimated that 40.3% of U.S. adults aged 20 and older had obesity during August 2021–August 2023. In the earlier 2017–2018 NHANES cycle, age-adjusted obesity prevalence was 49.6% among non-Hispanic Black adults, 44.8% among Hispanic adults, 42.2% among non-Hispanic White adults and 17.4% among non-Hispanic Asian adults.

Those are prevalence rates, not population shares. They cannot be compared directly with the percentage of a trial cohort in each category. Turning rates into an expected participant distribution requires a separate benchmark dataset, compatible categories, a defined geography and a stated year.

Peer-reviewed work has done explicit comparator analyses:

  • A 2024 BMJ Global Health systematic review and meta-analysis identified 27 randomized trials and 21,547 participants through a July 8, 2024 search cutoff and compared trial populations with several national populations.
  • A 2024 Lancet Diabetes & Endocrinology systematic review covered 246 randomized trials, 139,566 participants and 12 obesity medicines from January 1999 through November 12, 2023.
  • An earlier PRISMA review in the Journal of Racial and Ethnic Health Disparities examined 18 phase 3 and phase 4 obesity trials and documented inconsistency in race and ethnicity reporting.

Those analyses are the right sources for benchmarked representation questions. This page has a different job: current per-trial label demographics, including 2026 approvals and label additions that their search cutoffs could not include.

Sources: NCHS Data Brief 508 · NCHS Data Brief 360 and its race/ethnicity table · Jeyakumar et al., BMJ Global Health, 2024 · Alsaqaaby et al., The Lancet Diabetes & Endocrinology, 2024 · Johnson-Mann et al., Journal of Racial and Ethnic Health Disparities.

Why does this matter now?

Answer capsule: The oldest age bands remain small in the label-reported weight-management treatment populations at the same time that public access to these medicines is expanding. CMS launched the Medicare GLP-1 Bridge on July 1, 2026, allowing eligible Part D beneficiaries to obtain certain covered GLP-1 products for weight management with a $50 monthly copay.

The evidence statement needs to stay narrow.

What the data supports: the current labels report few drug-treated participants aged 75 or older in the weight-management populations summarized in Section 8.5.

What the data does not support: a conclusion that the medicines are unsafe or ineffective in older adults. A small subgroup limits precision. It does not demonstrate subgroup harm or benefit.

The same care applies to sex. The 72.5% versus 49.5% female split is a fact about enrollment. It is not evidence that treatment effects differ by sex.

For the separate access questions, The RX Index maintains independent reference pages on the Medicare GLP-1 Bridge, state Medicaid GLP-1 coverage and GLP-1 channel pricing and access. Each uses its own scope and methodology.

Primary policy source: Centers for Medicare & Medicaid Services, Medicare GLP-1 Bridge.

What are the limitations?

Answer capsule: The census is reproducible, but it is not individual-level data and it is not a universal inventory of every GLP-1 trial. Its strongest limitations are rounded source percentages, inconsistent field reporting, mixed trial designs and incompatible denominators between the trial census and the Geriatric Use snapshot.

We would rather state these plainly than have someone find them later.

  1. This is a current-label census, not every GLP-1 trial ever conducted. That is a narrower and more reproducible claim, and it is the only one this dataset supports.
  1. The source percentages are rounded. Every participant-weighted figure is an approximation, not a reconstruction of individual-level data.
  1. The labels do not report every field consistently. Asian participation is absent from all three Saxenda demographic paragraphs. Hispanic or Latino ethnicity is absent from Wegovy Study 6. American Indian or Alaska Native participation appears in only three of seventeen trials.
  1. The pooled population is not a single study population. It combines four products, multiple doses, different designs, different countries, different eligibility criteria and trials conducted across more than a decade.
  1. This dataset does not prove or disprove representativeness. That requires a stated comparator and compatible demographic categories.
  1. Four trials describe selected randomized populations. Participants had already lost weight, tolerated treatment or completed a lead-in before the demographic cohort was defined. Table 15 quantifies the effect.
  1. Race and ethnicity may not have been collected identically across trials. The labels do not provide enough detail to harmonize the underlying collection instruments.
  1. The age figures in Table 3 use different denominators from the 17-trial census. Section 8.5 reports drug-treated safety or treatment populations; Tables 7–10 report label-defined randomized cohorts. Zepbound's Section 8.5 count is limited to fixed-dose Studies 1 and 2.
  1. The current Wegovy cardiovascular age bands overlap at age 75 as written. We report them separately and do not derive a 65+ total for SELECT.
  1. The dataset describes enrollment, not treatment effects. Nothing here establishes that efficacy or adverse effects differed by age, sex, race or ethnicity.
  1. Trial enrollment is not real-world utilization. People using these medicines in routine care may differ substantially from the people studied.
  1. Foundayo's efficacy evidence came from an investigational orforglipron formulation. The label presents those data as equivalent approved doses; we keep that qualification attached.

Frequently asked questions

Answer capsule: These questions clarify the census boundary, the headline statistics and the limits of interpretation. The answers describe regulatory-source data and do not make treatment recommendations.

Are Ozempic and Mounjaro clinical trials included?

No. Ozempic and Mounjaro are diabetes product labels, while this census covers adult weight-management efficacy trials in weight-management product labels. Trials involving the same molecules appear only where the current Wegovy or Zepbound weight-management sections present them.

Why is tirzepatide included in a GLP-1 dataset?

Tirzepatide activates both GIP and GLP-1 receptors, and its label describes it as a GIP receptor and GLP-1 receptor agonist. We include it because "GLP-1" functions as the common umbrella term for current incretin-based weight-management medicines, while naming the dual mechanism wherever precision matters.

What percentage of GLP-1 trial participants were women?

Across the full 17-trial census, 67.0% were reported as female. Trials excluding type 2 diabetes were 72.5% female, while trials enrolling adults with type 2 diabetes were 49.5% female. Trial-level values ranged from 37% to 81%.

How many participants aged 75 and older were reported?

The four labels' Geriatric Use sections report 91 drug-treated participants aged 75 or older across five separately described weight-management treatment populations: Saxenda 17, Wegovy injection 23, Wegovy tablets 5, Zepbound 13 and Foundayo 33. This is not a count across all 21,063 randomized participants, and it should not be converted into a pooled percentage because the Section 8.5 denominators differ.

Were the GLP-1 trials racially diverse?

The census reports 73.7% White and 9.1% Black or African American participation, with Asian participation at 15.9% among reporting trials. Whether that is adequate diversity depends on a defined comparison population, and the current labels do not disclose a U.S.-only demographic subset for these full trial populations.

Are trial participants representative of people who actually take these medicines?

This dataset cannot answer that without a defined comparator and real-world utilization data. Trial eligibility, recruitment, geography, monitoring and treatment support differ from routine care, so trial enrollment should not be used as a direct measurement of current users.

Do these data prove that any group was underrepresented?

Not without a stated benchmark. A valid representation analysis must define the comparison population and use compatible demographic categories. This dataset provides current label-level composition; it does not issue a benchmark-free verdict.

Why do some fields say "not reported"?

Because the relevant label demographic paragraph did not report them. We preserve missing values as missing rather than converting them to zero or estimating them from another source.

Are pediatric GLP-1 trials included?

No. This is an adult census. Pediatric trials differ in eligibility, age distribution, regulatory framework and demographic reporting and should be analyzed separately.

How should this page be cited?

Answer capsule: The reference below identifies the publisher, page title, dataset version and verification date. It is provided as neutral attribution information so a specific edition can be identified after the dataset changes.

The RX Index Editorial Team. "GLP-1 Clinical Trial Demographics:
17 Trials, 21,063 Adults." The RX Index Research, version 1.0.
Last verified August 1, 2026.
https://therxindex.com/research/glp1-clinical-trial-demographics/

Version numbers and verification dates identify the exact edition used.

Data files: CSV, version 1.0 · JSON, version 1.0 · Data dictionary

Who produced this page, and how?

Answer capsule: The RX Index Editorial Team produced this resource by manually extracting current regulatory-source data, cross-checking trial identifiers and reproducing every aggregate from documented row-level inputs. The page is not clinician-reviewed and does not claim medical authority beyond the primary documents it cites.

Produced by: The RX Index Editorial Team.

How: Manual extraction from the current U.S. prescribing information for all four in-scope products; cross-checking of each trial against its ClinicalTrials.gov identifier; field-specific participant-weighted calculation from rounded label percentages; separate extraction of Section 8.5 age counts; and a sensitivity analysis excluding run-in-selected cohorts.

Why: The underlying information is scattered across four long PDFs that number studies differently, omit different fields and use incompatible age-reporting conventions. This resource puts the rows, missingness, source locations and arithmetic in one auditable place.

Not clinician-reviewed. This page has not been reviewed by a licensed clinician. It is an editorial research resource built from primary regulatory documents. It is not medical advice and should not be used to make a treatment decision. Consult the prescribing information and a qualified healthcare professional.

What changed?

Answer capsule: The public change log records every version that changes a value, source version, scope rule or method. The verification date changes only after the listed primary sources have actually been re-checked.

Evidence table
VersionDateChange
1.0August 1, 2026Initial publication. 17 trials and 21,063 label-reported baseline participants. Label versions: Saxenda revised February 2026, Wegovy revised June 2026, Zepbound revised February 2026 and Foundayo revised April 2026. Includes a separate five-population Section 8.5 older-adult snapshot.

Maintenance: We check FDA approvals and the four label revision dates monthly and re-audit every row quarterly. Every data change is recorded here.