{ "title": "GLP-1 Adult Weight-Management Clinical Trial Demographics Census", "publisher": "The RX Index Research", "creator": "The RX Index Editorial Team", "version": "1.0", "verification_date": "2026-08-01", "canonical_url": "https://therxindex.com/research/glp1-clinical-trial-demographics/", "scope": "Adult weight-reduction and long-term weight-maintenance efficacy trial cohorts in the current U.S. labels for Saxenda, Wegovy, Zepbound and Foundayo, with Section 8.5 older-adult treatment populations stored separately.", "overall": { "trials": 17, "participants": 21063, "mean_age_years": 47.9, "mean_age_years_denominator": 21063, "female_pct": 67.0, "female_pct_denominator": 21063, "white_pct": 73.7, "white_pct_denominator": 21063, "black_pct": 9.1, "black_pct_denominator": 21063, "asian_pct": 15.9, "asian_pct_denominator": 16275, "hispanic_latino_pct": 25.2, "hispanic_latino_pct_denominator": 20662 }, "trials": [ { "product": "Saxenda", "molecule": "liraglutide", "fda_study": "Study 1", "program_name": "SCALE Obesity & Prediabetes", "nct_id": "NCT01272219", "t2d_status": "Excluded", "n_demographic_cohort": 3731, "mean_age_years": 45, "female_pct": 79, "white_pct": 85, "black_pct": 10, "asian_pct": null, "aian_pct": null, "hispanic_latino_pct": 11, "selection_design": "Conventional randomized trial", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "19", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Saxenda", "molecule": "liraglutide", "fda_study": "Study 2", "program_name": "SCALE Diabetes", "nct_id": "NCT01272232", "t2d_status": "Included", "n_demographic_cohort": 635, "mean_age_years": 55, "female_pct": 50, "white_pct": 83, "black_pct": 12, "asian_pct": null, "aian_pct": null, "hispanic_latino_pct": 10, "selection_design": "Adults with type 2 diabetes", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "20", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Saxenda", "molecule": "liraglutide", "fda_study": "Study 3", "program_name": "SCALE Maintenance", "nct_id": "NCT00781937", "t2d_status": "Excluded", "n_demographic_cohort": 422, "mean_age_years": 46, "female_pct": 81, "white_pct": 84, "black_pct": 13, "asian_pct": null, "aian_pct": null, "hispanic_latino_pct": 7, "selection_design": "Only participants losing at least 5% during a 4–12-week diet run-in were randomized", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "20", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 2", "program_name": "STEP 1", "nct_id": "NCT03548935", "t2d_status": "Excluded", "n_demographic_cohort": 1961, "mean_age_years": 46, "female_pct": 74, "white_pct": 75, "black_pct": 6, "asian_pct": 13, "aian_pct": null, "hispanic_latino_pct": 12, "selection_design": "Wegovy injection 2.4 mg", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "30", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 3", "program_name": "STEP 2", "nct_id": "NCT03552757", "t2d_status": "Included", "n_demographic_cohort": 807, "mean_age_years": 55, "female_pct": 51, "white_pct": 62, "black_pct": 8, "asian_pct": 26, "aian_pct": null, "hispanic_latino_pct": 13, "selection_design": "Adults with type 2 diabetes", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "30", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 4", "program_name": "STEP 3", "nct_id": "NCT03611582", "t2d_status": "Excluded", "n_demographic_cohort": 611, "mean_age_years": 46, "female_pct": 81, "white_pct": 76, "black_pct": 19, "asian_pct": 2, "aian_pct": null, "hispanic_latino_pct": 20, "selection_design": "Intensive behavioral therapy during the trial", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "30", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 5", "program_name": "STEP 4", "nct_id": "NCT03548987", "t2d_status": "Excluded", "n_demographic_cohort": 803, "mean_age_years": 46, "female_pct": 79, "white_pct": 84, "black_pct": 13, "asian_pct": 2, "aian_pct": null, "hispanic_latino_pct": 8, "selection_design": "Randomized after a 20-week Wegovy run-in; 902 entered and 803 were randomized", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "30", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 6", "program_name": "STEP 6", "nct_id": "NCT03811574", "t2d_status": "Mixed; 24.7% had T2D", "n_demographic_cohort": 401, "mean_age_years": 51, "female_pct": 37, "white_pct": 0, "black_pct": 0, "asian_pct": 100, "aian_pct": null, "hispanic_latino_pct": null, "selection_design": "East Asian trial conducted in Japan and South Korea", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "30–31", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "white_pct=0 and black_pct=0 derived from label statement that all participants were Asian" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 7", "program_name": "OASIS 4", "nct_id": "NCT05564117", "t2d_status": "Excluded", "n_demographic_cohort": 307, "mean_age_years": 48, "female_pct": 79, "white_pct": 92, "black_pct": 7, "asian_pct": 1, "aian_pct": null, "hispanic_latino_pct": 7.8, "selection_design": "Oral Wegovy 25 mg", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "31", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 8", "program_name": "STEP UP", "nct_id": "NCT05646706", "t2d_status": "Excluded", "n_demographic_cohort": 1407, "mean_age_years": 47, "female_pct": 74, "white_pct": 86, "black_pct": 9, "asian_pct": 4, "aian_pct": null, "hispanic_latino_pct": 5, "selection_design": "Wegovy 7.2 mg, 2.4 mg or placebo", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "31", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Wegovy", "molecule": "semaglutide", "fda_study": "Study 9", "program_name": "STEP UP T2D", "nct_id": "NCT05649137", "t2d_status": "Included", "n_demographic_cohort": 512, "mean_age_years": 56, "female_pct": 52, "white_pct": 84, "black_pct": 9, "asian_pct": 6, "aian_pct": null, "hispanic_latino_pct": 6, "selection_design": "Wegovy 7.2 mg in adults with type 2 diabetes", "source_label_revision": "2026-06", "source_section": "14.2", "source_pdf_page_1_based": "31", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Zepbound", "molecule": "tirzepatide", "fda_study": "Study 1", "program_name": "SURMOUNT-1", "nct_id": "NCT04184622", "t2d_status": "Excluded", "n_demographic_cohort": 2539, "mean_age_years": 45, "female_pct": 68, "white_pct": 71, "black_pct": 8, "asian_pct": 11, "aian_pct": 9, "hispanic_latino_pct": 48, "selection_design": "Fixed-dose weight-reduction trial", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "15", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Zepbound", "molecule": "tirzepatide", "fda_study": "Study 2", "program_name": "SURMOUNT-2", "nct_id": "NCT04657003", "t2d_status": "Included", "n_demographic_cohort": 938, "mean_age_years": 54, "female_pct": 51, "white_pct": 76, "black_pct": 8, "asian_pct": 13, "aian_pct": null, "hispanic_latino_pct": 60, "selection_design": "Adults with type 2 diabetes", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "15", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Zepbound", "molecule": "tirzepatide", "fda_study": "Study 3", "program_name": "SURMOUNT-3", "nct_id": "NCT04657016", "t2d_status": "Excluded", "n_demographic_cohort": 579, "mean_age_years": 46, "female_pct": 63, "white_pct": 86, "black_pct": 11, "asian_pct": 1, "aian_pct": null, "hispanic_latino_pct": 54, "selection_design": "Only participants losing at least 5% during a 12-week lifestyle lead-in were randomized; 806 initially enrolled and 579 were randomized", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "22", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Zepbound", "molecule": "tirzepatide", "fda_study": "Study 4", "program_name": "SURMOUNT-4", "nct_id": "NCT04660643", "t2d_status": "Excluded", "n_demographic_cohort": 670, "mean_age_years": 49, "female_pct": 71, "white_pct": 80, "black_pct": 11, "asian_pct": 7, "aian_pct": null, "hispanic_latino_pct": 44, "selection_design": "Randomized after a 36-week open-label Zepbound lead-in; 783 entered and 670 were randomized", "source_label_revision": "2026-02", "source_section": "14.1", "source_pdf_page_1_based": "25", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Foundayo", "molecule": "orforglipron", "fda_study": "Trial 1", "program_name": "ATTAIN-1", "nct_id": "NCT05869903", "t2d_status": "Excluded", "n_demographic_cohort": 3127, "mean_age_years": 45, "female_pct": 64, "white_pct": 56, "black_pct": 9, "asian_pct": 28, "aian_pct": 0.4, "hispanic_latino_pct": 38, "selection_design": "72-week trial", "source_label_revision": "2026-04", "source_section": "14", "source_pdf_page_1_based": "15", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" }, { "product": "Foundayo", "molecule": "orforglipron", "fda_study": "Trial 2", "program_name": "ATTAIN-2", "nct_id": "NCT05872620", "t2d_status": "Included", "n_demographic_cohort": 1613, "mean_age_years": 57, "female_pct": 47, "white_pct": 71, "black_pct": 7, "asian_pct": 17, "aian_pct": 0.3, "hispanic_latino_pct": 30, "selection_design": "72-week trial in adults with type 2 diabetes", "source_label_revision": "2026-04", "source_section": "14", "source_pdf_page_1_based": "15", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "verification_date": "2026-08-01", "data_version": "1.0", "derived_fields": "" } ], "older_adult_populations": [ { "product_population": "Saxenda adult clinical trials", "age_65_plus_count": 232, "age_65_plus_pct": 6.9, "age_75_plus_count": 17, "age_75_plus_pct": 0.5, "reporting_convention": "Nested: age 75+ is included in age 65+", "source_section": "8.5", "source_pdf_page_1_based": "15", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf" }, { "product_population": "Wegovy injection weight-reduction and maintenance trials", "age_65_plus_count": 256, "age_65_plus_pct": 10.0, "age_75_plus_count": 23, "age_75_plus_pct": 1.0, "reporting_convention": "Derived count and approximate rate: 233 (9%) age 65 to <75 plus 23 (1%) age 75+", "source_section": "8.5", "source_pdf_page_1_based": "21", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf" }, { "product_population": "Wegovy tablets weight-reduction and maintenance trial", "age_65_plus_count": 21, "age_65_plus_pct": 10.0, "age_75_plus_count": 5, "age_75_plus_pct": 2.0, "reporting_convention": "Derived count and approximate rate: 16 (8%) age 65 to <75 plus 5 (2%) age 75+", "source_section": "8.5", "source_pdf_page_1_based": "21", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf" }, { "product_population": "Zepbound fixed-dose Studies 1 and 2", "age_65_plus_count": 226, "age_65_plus_pct": 9.0, "age_75_plus_count": 13, "age_75_plus_pct": 0.5, "reporting_convention": "Nested: age 75+ is included in age 65+; limited to fixed-dose Studies 1 and 2", "source_section": "8.5", "source_pdf_page_1_based": "11", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf" }, { "product_population": "Foundayo-treated participants in pooled Trials 1 and 2", "age_65_plus_count": 399, "age_65_plus_pct": 13.0, "age_75_plus_count": 33, "age_75_plus_pct": 1.0, "reporting_convention": "Nested: age 75+ is included in age 65+", "source_section": "8.5", "source_pdf_page_1_based": "11", "source_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf" } ], "notes": [ "Source percentages are rounded; participant-weighted aggregates are approximate.", "Race and Hispanic or Latino ethnicity are separate dimensions.", "Blank or null demographic values mean not separately reported.", "Section 8.5 age populations use different denominators from the 17-trial census." ] }