{
  "name": "GLP-1 Clinical Trial Eligibility and Exclusion Criteria: 17 Pivotal Weight-Management Trials",
  "version": "1.1",
  "lastVerified": "2026-08-03",
  "publisher": "The RX Index",
  "creator": "The RX Index Editorial Team",
  "scope": "Adult chronic-weight-management efficacy trials named in current U.S. prescribing information; excludes cardiovascular-outcomes, sleep-apnea, MASH, pediatric, and non-pivotal head-to-head trials.",
  "coding": {
    "Y — explicit": "Eligibility rule or normalized domain explicitly reported in the reviewed public primary source.",
    "Y — inherited": "FDA explicitly stated that the trial inherited the general criteria from another named trial.",
    "NR-P": "Not reported in the public source reviewed; this is not evidence that the criterion was absent."
  },
  "columns": [
    "Trial",
    "NCT",
    "Drug",
    "Population",
    "Source detail",
    "Recent weight-stability eligibility rule / >5 kg change",
    "Recent anti-obesity medication",
    "Prior/planned bariatric procedure or device",
    "Pancreatitis history",
    "Psychiatric eligibility exclusion",
    "Suicide-specific screening",
    "MTC / MEN2 / calcitonin",
    "Numeric kidney-function cutoff",
    "Recent cardiovascular event/window",
    "Numeric liver-test thresholds",
    "BP ≥160/100 mmHg",
    "Retinopathy treatment/status",
    "Recent or active malignancy",
    "Numeric TSH range",
    "Severe gastric emptying / GI motility",
    "Notes",
    "Primary detail URL",
    "Registry URL",
    "Last verified"
  ],
  "records": [
    {
      "Trial": "SCALE Obesity and Prediabetes",
      "NCT": "NCT01272219",
      "Drug": "Liraglutide",
      "Population": "No T2D",
      "Source detail": "Regulator evaluation",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "NR-P",
      "Recent cardiovascular event/window": "NR-P",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "NR-P",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Public regulator summary. NR-P is not evidence of absence.",
      "Primary detail URL": "https://www.tga.gov.au/sites/default/files/auspar-liraglutide-160323-cer.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT01272219",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SCALE Diabetes",
      "NCT": "NCT01272232",
      "Drug": "Liraglutide",
      "Population": "T2D",
      "Source detail": "Full sponsor protocol + regulator evaluation",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "NR-P",
      "Recent cardiovascular event/window": "NR-P",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Full Novo Nordisk protocol NN8022-1922 v6.0 (6 Mar 2012) was available as Supplement 2 to the trial publication; regulator material was used for cross-checking.",
      "Primary detail URL": "https://jamanetwork.com/journals/jama/fullarticle/2428956",
      "Registry URL": "https://clinicaltrials.gov/study/NCT01272232",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SCALE Maintenance",
      "NCT": "NCT00781937",
      "Drug": "Liraglutide",
      "Population": "No T2D; post-diet run-in",
      "Source detail": "Regulator evaluation",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "NR-P",
      "Numeric kidney-function cutoff": "NR-P",
      "Recent cardiovascular event/window": "NR-P",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Broad renal, hepatic, cardiovascular impairment and uncontrolled hypertension were excluded, but reviewed public text did not provide the normalized numeric cutoffs used in this matrix.",
      "Primary detail URL": "https://www.tga.gov.au/sites/default/files/auspar-liraglutide-160323-cer.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT00781937",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP 1",
      "NCT": "NCT03548935",
      "Drug": "Semaglutide injection",
      "Population": "No T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Core STEP psychiatric screen included severe psychiatric disorder, PHQ-9, lifetime attempt, and recent C-SSRS criteria.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/35/NCT03548935/Prot_002.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT03548935",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP 2",
      "NCT": "NCT03552757",
      "Drug": "Semaglutide injection",
      "Population": "T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "T2D-specific medication and retinopathy restrictions applied.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/57/NCT03552757/Prot_002.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT03552757",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP 3",
      "NCT": "NCT03611582",
      "Drug": "Semaglutide injection",
      "Population": "No T2D; intensive behavioral therapy",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Intensive behavioral therapy was part of the design; core protocol exclusions remained broad.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/82/NCT03611582/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT03611582",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP 4",
      "NCT": "NCT03548987",
      "Drug": "Semaglutide injection",
      "Population": "No T2D; randomized withdrawal",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Eligibility applied before the semaglutide run-in; randomization also required tolerating and reaching the target dose.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/87/NCT03548987/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT03548987",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP 6",
      "NCT": "NCT03811574",
      "Drug": "Semaglutide injection",
      "Population": "East Asian; with/without T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Retinopathy restriction applied to the T2D stratum.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/74/NCT03811574/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT03811574",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "OASIS 4",
      "NCT": "NCT05564117",
      "Drug": "Oral semaglutide",
      "Population": "No T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Oral semaglutide 25 mg formulation; the 64-week OASIS 4 eligibility pattern remained closely aligned with the STEP program. The public protocol explicitly excluded uncontrolled thyroid disease at the investigator's discretion, but did not specify a numeric TSH range.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/17/NCT05564117/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT05564117",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP UP",
      "NCT": "NCT05646706",
      "Drug": "Semaglutide injection 7.2 mg",
      "Population": "No T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "Higher-dose semaglutide trial included in the current U.S. Wegovy label. The public protocol explicitly excluded uncontrolled thyroid disease at the investigator's discretion, but did not specify a numeric TSH range.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/06/NCT05646706/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT05646706",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "STEP UP T2D",
      "NCT": "NCT05649137",
      "Drug": "Semaglutide injection 7.2 mg",
      "Population": "T2D",
      "Source detail": "Full protocol + SAP",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "NR-P",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "T2D-specific medication, kidney, and retinopathy restrictions applied. The public protocol explicitly excluded uncontrolled thyroid disease at the investigator's discretion, but did not specify a numeric TSH range.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/37/NCT05649137/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT05649137",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SURMOUNT-1",
      "NCT": "NCT04184622",
      "Drug": "Tirzepatide",
      "Population": "No T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "Y — explicit",
      "Notes": "Numeric BP, liver, calcitonin, kidney, and 3-month cardiovascular thresholds were explicit.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/22/NCT04184622/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT04184622",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SURMOUNT-2",
      "NCT": "NCT04657003",
      "Drug": "Tirzepatide",
      "Population": "T2D",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "Y — explicit",
      "Notes": "T2D-specific severe hypoglycemia, medication, and retinopathy criteria applied.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/03/NCT04657003/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT04657003",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SURMOUNT-3",
      "NCT": "NCT04657016",
      "Drug": "Tirzepatide",
      "Population": "No T2D; lifestyle lead-in",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "Y — explicit",
      "Notes": "Some criteria were re-applied during the intensive lifestyle lead-in.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/16/NCT04657016/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT04657016",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "SURMOUNT-4",
      "NCT": "NCT04660643",
      "Drug": "Tirzepatide",
      "Population": "No T2D; randomized withdrawal",
      "Source detail": "Full protocol",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "Y — explicit",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "Y — explicit",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "Y — explicit",
      "Severe gastric emptying / GI motility": "Y — explicit",
      "Notes": "Eligibility preceded the tirzepatide lead-in; randomization required remaining on treatment.",
      "Primary detail URL": "https://cdn.clinicaltrials.gov/large-docs/43/NCT04660643/Prot_000.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT04660643",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "ATTAIN-1",
      "NCT": "NCT05869903",
      "Drug": "Orforglipron",
      "Population": "No T2D",
      "Source detail": "FDA review + official registry",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — explicit",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — explicit",
      "Suicide-specific screening": "NR-P",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "NR-P",
      "Recent cardiovascular event/window": "NR-P",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "NR-P",
      "Recent or active malignancy": "NR-P",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "NR-P",
      "Notes": "FDA identified a 180-day weight-loss-drug washout, 12-month stability for weight-gain medications, liver thresholds, and a 2-year severe-psychiatric-disorder exclusion. The public registry explicitly reports weight change, MTC/MEN2, and pancreatitis.",
      "Primary detail URL": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/220934Orig1s000MultidisciplineR.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT05869903",
      "Last verified": "2026-08-03"
    },
    {
      "Trial": "ATTAIN-2",
      "NCT": "NCT05872620",
      "Drug": "Orforglipron",
      "Population": "T2D",
      "Source detail": "FDA review + official registry",
      "Recent weight-stability eligibility rule / >5 kg change": "Y — explicit",
      "Recent anti-obesity medication": "Y — explicit",
      "Prior/planned bariatric procedure or device": "Y — inherited",
      "Pancreatitis history": "Y — explicit",
      "Psychiatric eligibility exclusion": "Y — inherited",
      "Suicide-specific screening": "NR-P",
      "MTC / MEN2 / calcitonin": "Y — explicit",
      "Numeric kidney-function cutoff": "Y — explicit",
      "Recent cardiovascular event/window": "Y — explicit",
      "Numeric liver-test thresholds": "Y — explicit",
      "BP ≥160/100 mmHg": "NR-P",
      "Retinopathy treatment/status": "Y — explicit",
      "Recent or active malignancy": "Y — explicit",
      "Numeric TSH range": "NR-P",
      "Severe gastric emptying / GI motility": "Y — explicit",
      "Notes": "FDA states general ATTAIN-1 eligibility criteria also applied. Additional ATTAIN-2 criteria included eGFR <15, 90-day cardiovascular conditions, gastric-emptying abnormality, retinopathy treatment, liver thresholds, calcitonin cutoffs, and T2D-specific glycemic exclusions.",
      "Primary detail URL": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/220934Orig1s000MultidisciplineR.pdf",
      "Registry URL": "https://clinicaltrials.gov/study/NCT05872620",
      "Last verified": "2026-08-03"
    }
  ]
}