What GLP-1 Clinical Trials Actually Showed
Every major trial's results in one place — weight loss by estimand, responder rates, cardiovascular outcomes from SELECT, completion rates, and trial exclusion criteria.
Last updated: May 4, 2026
GLP-1 trials report weight loss in two ways. The on-treatment estimand, also called the efficacy estimand, estimates the effect if all participants had taken the drug as intended.The intention-to-treat (ITT) estimand includes all randomized participants, whether or not they stayed on the drug through the end of trial. Most published trial reports provide both, but vendor and press materials typically cite the on-treatment figure, which runs 0.7–3.0 percentage points higher. This page shows both estimands side by side for every major trial, along with the context needed to interpret them.
The data
Every major trial, side by side
Click any column header to sort. Use the drug filter to narrow results. Weight-loss figures are mean change from baseline. Both on-treatment and ITT estimands are shown where published.
| Trial ▼ | Drug & dose ▼ | N ▼ | Population ▼ | Duration ▼ | Wt loss, on-tx ▼ | Wt loss, ITT ▼ |
|---|---|---|---|---|---|---|
| STEP 1NEJM, 2021Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 1,961 | Obesity, no T2D | 68 wk | −16.9% | −14.9% |
| STEP 2Lancet, 2021Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 1,210 | Overweight/obesity + T2D | 68 wk | −10.6%ᴬ | −9.6% |
| STEP 3JAMA, 2021Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly + IBT | 611 | Obesity, intensive behavioral tx | 68 wk | −17.6%ᴬ | −16.0% |
| STEP 4JAMA, 2021Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly (withdrawal design) | 803 | Obesity, no T2D | 68 wk | −18.2% | −17.4% |
| STEP 5Nat Med, 2022Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 304 | Obesity, no T2D | 104 wk | −16.7%ᴬ | −15.2% |
| STEP-HFpEFNEJM, 2023Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 529 | Obesity + HFpEF, no T2D | 52 wk | — | −13.3% |
| STEP-HFpEF DMNEJM, 2024Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 616 | Obesity + HFpEF + T2D | 52 wk | — | −9.8% |
| SELECTNEJM, 2023Approved as Wegovy | Semaglutide 2.4 mgInjection, weekly | 17,604 | Overweight/obesity + CVD, no T2D | 208 wkᴮ | −11.7% | −10.2% |
| SURMOUNT-1 (15 mg)NEJM, 2022Approved as Zepbound | Tirzepatide 15 mgInjection, weekly | 2,539 | Obesity, no T2D | 72 wk | −22.5% | −20.9% |
| SURMOUNT-1 (10 mg)NEJM, 2022Approved as Zepbound | Tirzepatide 10 mgInjection, weekly | 2,539 | Obesity, no T2D | 72 wk | −21.4% | −19.5% |
| SURMOUNT-1 (5 mg)NEJM, 2022Approved as Zepbound | Tirzepatide 5 mgInjection, weekly | 2,539 | Obesity, no T2D | 72 wk | −16.0% | −15.0% |
| SURMOUNT-2 (15 mg)Lancet, 2023Approved as Zepbound | Tirzepatide 15 mgInjection, weekly | 938 | Overweight/obesity + T2D | 72 wk | −15.7% | −14.7% |
| SURMOUNT-3Nat Med, 2023Approved as Zepbound | Tirzepatide 10/15 mgInjection, weekly (MTD) | 579 | Obesity, post-lifestyle lead-in | 84 wk total | −21.1% | −18.4% |
| SURMOUNT-4JAMA, 2024Approved as Zepbound | Tirzepatide 10/15 mgInjection, weekly (withdrawal design) | 670 | Obesity, no T2D | 88 wk total | ~−26% | −25.3% |
| SURMOUNT-5NEJM, 2025Head-to-head | Tirzepatide MTD vs. semaglutide MTD10/15 mg vs. 1.7/2.4 mg (open-label)ᴳ | 751 | Obesity, no T2D, ≥1 comorbidity | 72 wk | —ᴳ | −20.2% vs. −13.7% |
| OASIS 1Lancet, 2023Investigational | Semaglutide 50 mgOral, daily | 667 | Obesity, no T2D | 68 wk | −17.4% | −15.1% |
| OASIS 4NEJM, 2025Approved as Wegovy (oral) | Semaglutide 25 mgOral, daily | 307 | Obesity, no T2D | 64 wk | −16.6% | −13.6% |
| ATTAIN-1NEJM, 2025Approved as Foundayo | Orforglipron 36 mgOral, daily | 3,127 | Obesity, no T2D | 72 wk | −12.4% | −11.1% |
| ATTAIN-2Lancet, 2025Approved as Foundayo | Orforglipron 36 mgOral, daily | 1,613 | Overweight/obesity + T2D | 72 wk | −10.5% | −9.6% |
| REDEFINE 1NEJM, 2025Investigational | CagriSema 2.4/2.4 mgInjection, weekly | 3,417 | Obesity, no T2D | 68 wk | −22.7% | −20.4% |
| REDEFINE 2NEJM, 2025Investigational | CagriSema 2.4/2.4 mgInjection, weekly | 1,206 | Overweight/obesity + T2D | 68 wk | — | −13.7% |
| RetatrutideNEJM, 2023 (Ph2)Investigational | Retatrutide 12 mgInjection, weekly | 338 | Obesity, no T2D | 48 wk | −24.2%ᶜ | — |
| SurvodutideLancet D&E, 2024 (Ph2)Investigational | Survodutide 4.8 mgInjection, weekly | 386 | Obesity | 46 wk | −18.7%ᶜ | — |
| MaritideNEJM, 2025 (Ph2)Investigational | Maritide 420 mgInjection, monthly | 592 | Obesity | 52 wk | ~−20% | −16.2% |
Estimand definitions. On-tx = on-treatment / efficacy estimand (effect if treatment taken as intended). ITT = treatment-policy / intention-to-treat estimand (effect across all randomized participants, regardless of discontinuation). Full retention data for each trial appears in the retention section.
A. Approximated on-treatment values. STEP 2, STEP 3, and STEP 5 report the ITT estimand in the primary publication; the on-treatment values shown here are calculated from supplementary tables or press materials using the ITT figure plus the published ITT/on-treatment gap from STEP 1 and STEP 4 as a reference.
B. SELECT duration. The −11.7% / −10.2% weight-loss figures are from week 208 (Ryan et al., Nat Med 2024). The 39.8-month mean follow-up cited in the primary SELECT publication refers to the MACE composite endpoint, not the weight-loss measurement timepoint.
C. Retatrutide and Phase 2 reporting. Retatrutide and survodutide Phase 2 trials report the on-treatment (completers / efficacy) estimand only; no ITT analysis was published. Maritide Phase 2 reports both. Retatrutide Phase 3 topline results from TRIUMPH-4 (obesity + knee OA, Dec 2025) reported −28.7% weight loss on-treatment and -23.7% ITT at 12 mg (Lilly); peer-reviewed publication pending.
G. SURMOUNT-5 design. The only published head-to-head obesity RCT between two GLP-1 agents. Open-label; no placebo arm. Both arms titrated to maximum tolerated dose: tirzepatide 10 or 15 mg; semaglutide 1.7 or 2.4 mg. The −20.2% figure is the treatment-regimen (ITT) estimand; the on-tx / efficacy estimand was not separately reported as the primary endpoint. Comparator arm (semaglutide MTD) achieved −13.7% (95% CI −14.9 to −12.6), P<0.001. Secondary endpoints: 31.6% of tirzepatide participants vs. 16.1% of semaglutide participants reached ≥25% weight loss. Waist circumference: −18.4 cm vs. −13.0 cm.
Distribution of response
Responder rates at clinical thresholds
Percentage of participants achieving each weight-loss threshold, reported using the ITT / treatment-policy estimand where available.
| Trial ▼ | Drug ▼ | ≥5% ▼ | ≥10% ▼ | ≥15% ▼ | ≥20% ▼ | ≥25% ▼ |
|---|---|---|---|---|---|---|
| STEP 1 | Semaglutide 2.4 mg | 86.4% | 69.1% | 50.5% | 32.0% | — |
| STEP 2 (T2D) | Semaglutide 2.4 mg | 68.8% | ~45.6% | ~25.8% | — | — |
| STEP 3 (IBT) | Semaglutide 2.4 mg | 86.6% | 75.3% | 55.8% | ~36% | — |
| STEP 5 (104 wk) | Semaglutide 2.4 mg | 77.1% | 61.8% | 52.1% | 36.1% | — |
| SURMOUNT-1 (15 mg) | Tirzepatide 15 mg | 91% | 84% | ~73% | 57% | 36.2% |
| SURMOUNT-1 (10 mg) | Tirzepatide 10 mg | 89% | 78% | ~65% | 50% | 32.3% |
| SURMOUNT-1 (5 mg) | Tirzepatide 5 mg | 85% | 69% | ~55% | 30% | 15.3% |
| OASIS 1 | Semaglutide 50 mg (oral) | 85% | 69% | 54% | 34% | — |
| ATTAIN-1 (ITT) | Orforglipron 36 mg | ~70% | 54.6% | 36.0% | 18.4% | — |
| ATTAIN-2 (ITT, T2D) | Orforglipron 36 mg | ~60% | 45.6% | 26.0% | — | — |
| REDEFINE 1 (ITT) | CagriSema | 91.9% | ~80% | ~65% | ~50% | 34.7% |
Trial means obscure individual response distribution. Across the STEP program, 10–17% of semaglutide-treated participants lost less than 5% body weight; 32–40% achieved ≥20%. Presence of T2D consistently attenuated response: STEP 2 (T2D) showed roughly 35% less weight loss than STEP 1 (no T2D); SURMOUNT-2 vs. SURMOUNT-1 showed a similar pattern.
Real-world weight loss in commercial populations runs lower than trial ITT figures, driven primarily by shorter time on drug and lower mean dose reached. See page 3 (persistence) and page 4 (weight regain).
Cardiovascular evidence
SELECT — cardiovascular outcomes trial
SELECT (N=17,604; mean follow-up 39.8 months) is the pivotal cardiovascular outcomes trial for a GLP-1 in a population without diabetes. Semaglutide 2.4 mg reduced 3-point MACE — the standard cardiovascular composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke — by 20% in adults with established cardiovascular disease and overweight/obesity.
| Endpoint | Semaglutide | Placebo | HR (95% CI) | Significance |
|---|---|---|---|---|
| 3-point MACE (primary) | 6.5% | 8.0% | 0.80 (0.72–0.90) | P<0.001 ✓ |
| Nonfatal MI | 2.7% | 3.7% | 0.72 (0.61–0.85) | Significant |
| CV death | 2.5% | 3.0% | 0.85 (0.71–1.01) | P=0.07 — hierarchy stoppedᴬ |
| All-cause death | 4.3% | 5.2% | 0.81 (0.71–0.93) | Nominalᴬ |
| HF composite | 3.4% | 4.1% | 0.82 (0.71–0.96) | Nominalᴬ |
| New-onset diabetes | 3.5% | 12.0% | 0.27 (0.24–0.31) | 73% reduction (prespecified) |
A. "Nominal" vs. confirmed significance. SELECT prespecified a hierarchical testing order for confirmatory secondary endpoints: CV death → HF composite → all-cause death. CV death came in at P=0.07, not crossing the 0.023 threshold required after interim-analysis adjustment. When hierarchical testing stops at a prior step, subsequent endpoints cannot formally claim superiority even when their point estimates and confidence intervals favor the drug — they are called nominal rather than confirmed. All-cause death (HR 0.81, 95% CI 0.71–0.93) and HF composite (HR 0.82, 95% CI 0.71–0.96) fall into this category: directionally positive, but not formally confirmed per the prespecified statistical plan.
Mechanism. A 2025 Lancet mediation analysis (Deanfield et al.) found that waist-circumference reduction mediated approximately 33% of the MACE benefit, suggesting most of the cardiovascular benefit operates through pathways other than weight loss. hsCRP declined by week 4, before significant weight loss occurred. Over the full trial period, hsCRP decreased ~38–39% versus placebo.
Heart failure subgroup. Among participants with baseline heart failure (N=4,286), MACE HR was 0.72 (0.60–0.87), with consistent benefit across HFpEF (HR 0.69) and HFrEF (HR 0.65) subtypes (Deanfield et al., Lancet 2024).
Long-term weight loss in SELECT. Mean weight change at week 208 was −10.2% (ITT) / −11.7% (on-treatment) versus −1.5% placebo (Ryan et al., Nat Med 2024). SELECT did not include structured lifestyle intervention — see the concomitant interventions section below.
Retention
Trial retention and real-world persistence
Trials report two retention measures: study completion (percentage who completed the assessment period, whether or not they were still on drug) and on-drug at end (percentage still taking study drug at final visit). Real-world persistence data from commercial claims measures prescription refill continuity. The table below reports all three so readers can make like-for-like comparisons. GI adverse events were the dominant reason for drug discontinuation across every trial program.
| Trial ▼ | Trial completion ▼ | On drug at end ▼ | AE discontinuation ▼ | Primary reasons ▼ |
|---|---|---|---|---|
| STEP 1 | 94.3% | 81.1% | 4.5% | GI AEs, consent withdrawal |
| STEP 2 | 96% | 87% | ~4–5% | GI AEs, rescue therapy |
| STEP 3 | 92.8% | 82.7% | 3.4% | GI AEs |
| STEP 4 | 98.0% | 92.3% | Low | Pre-selected tolerators (withdrawal design) |
| STEP 5 | 92.8% | ~85% | 5.9–7.7% | GI AEs |
| STEP-HFpEF | ~87% | ~87% | 13.3% | GI AEs, cardiac events |
| STEP-HFpEF DM | ~82% | ~82% | Higher vs. placebo | GI AEs |
| SELECT | 96.9%ᴬ | 73.3% | 16.6% | GI AEs (10.0% sema vs. 2.0% placebo) |
| SURMOUNT-1 | 86% | 84–86% | 4.3–7.1% | GI AEs, consent withdrawal |
| SURMOUNT-2 | ~86–91% | ~85–91% | <5% | GI AEs |
| SURMOUNT-3 | ~85–90% | ~85% | 4–10.5% | GI AEs |
| SURMOUNT-4 | 85.6% | High | ~5–7% | GI AEs |
| OASIS 1 | ~82% | 86% | ~5–7% | GI AEs (nausea, vomiting) |
| OASIS 4 | 81.5% | ~81% | 7% | GI AEs (nausea 47%, vomiting 31%) |
| ATTAIN-1 (36 mg) | ~76% | ~76% | 10.3% | GI AEs |
| ATTAIN-2 (36 mg) | ~78–81% | ~78% | 10.6% | GI AEs |
| REDEFINE 1 | ~90% | ~90% | ~6% | GI AEs |
Completion = percentage who completed the trial assessment period (may include participants who stopped drug but remained in study). On drug at end = percentage still taking study drug at trial end. AE discontinuation = percentage who stopped drug specifically due to adverse events. GI adverse events (nausea, vomiting, diarrhea, constipation) were the dominant discontinuation reason in every program.
A. SELECT retention paradox. SELECT's 96.9% completion rate is often confused with its lower on-drug retention of 73.3%. The difference matters: the primary MACE analysis is ITT and benefits from near-complete event ascertainment, but 26.7% of the semaglutide arm had permanently discontinued drug by trial end. The primary weight-loss and risk-factor analyses from SELECT are materially affected by this drug-discontinuation pattern.
Real-world persistence data — the gap between these trial rates and what employer populations experience — is covered on page 3 of this series.
Safety
Adverse events in pivotal trials
Gastrointestinal adverse event rates by drug and dose, reported from pivotal trial publications and FDA prescribing information. GI symptoms are the most common adverse events across every agent in the class and the dominant reason for drug discontinuation. Serious and rare adverse events — gallbladder disease, pancreatitis meta-analyses, thyroid C-cell findings, NAION, long-term malignancy data — are covered on page 6.
All percentages reflect any-grade gastrointestinal events during the trial period. Maintenance-dose subgroups reported where available; otherwise pooled trial rates.
| Drug & dose ▼ | Nausea ▼ | Vomiting ▼ | Diarrhea ▼ | Constipation ▼ | AE discontinuation ▼ | Source ▼ |
|---|---|---|---|---|---|---|
| Semaglutide 2.4 mg inj.Obesity (Wegovy) | 43.9% | 24.5% | 29.7% | 24.2% | 6.8% | STEP 1–3 pooled |
| Semaglutide 2.4 mg inj.Obesity + CVD (SELECT) | ~19% | ~10% | ~14% | ~12% | 16.6%ᴬ | SELECT |
| Semaglutide 25 mg oralObesity (Wegovy tablet) | ~35% | ~20% | ~19% | ~18% | ~8% | OASIS 4 |
| Tirzepatide 5 mg inj.Obesity (Zepbound) | 11.6% | 5.4% | 12.9% | 6.7% | 4.3% | SURMOUNT-1 |
| Tirzepatide 10 mg inj.Obesity (Zepbound) | ~25% | 9.5% | 21.2% | ~11% | 7.1% | SURMOUNT-1 |
| Tirzepatide 15 mg inj.Obesity (Zepbound) | 29.6% | 12.2% | 23% | 11.7% | 6.2% | SURMOUNT-1 |
| Tirzepatide MTD vs. semaglutide MTDObesity, head-to-head (SURMOUNT-5) | 44% vs. 50% | 16% vs. 25% | 25% vs. 22% | 16% vs. 20% | 6.1% vs. 8.0%ᴮ | SURMOUNT-5 |
| Orforglipron 36 mg oralObesity (Foundayo) | ~34% | ~22% | ~26% | ~15% | 10.3% | ATTAIN-1 |
| PlaceboPooled across obesity trials | ~10–16% | ~3–6% | ~8–16% | ~6–11% | 2.6–3.2% | Placebo arms, STEP + SURMOUNT |
Dose escalation. GI adverse event rates peak during the 16–20 week dose-titration period and decline thereafter. 98% of GI events in pooled STEP analyses were mild or moderate; 99.5% were non-serious (Wharton et al., Diabetes Obes Metab, 2022; DOI: 10.1111/dom.14551).
A. SELECT discontinuation. SELECT's 16.6% AE discontinuation rate reflects 3.3-year mean exposure in an older (mean age 61.6) ASCVD population — substantially higher than the 68-week obesity trials. 10.0% of SELECT semaglutide participants discontinued specifically for GI AEs, versus 2.0% on placebo.
B. SURMOUNT-5 comparator rates. Open-label head-to-head (tirzepatide MTD 10 or 15 mg vs. semaglutide MTD 1.7 or 2.4 mg) in obesity without T2D, 72 weeks. GI-related discontinuation was 2.7% tirzepatide vs. 5.6% semaglutide. Source: Aronne et al., NEJM, 2025.
C. Suicidality warning removed. FDA requested removal of the suicidal-behavior-and-ideation warning from Wegovy, Saxenda, and Zepbound labels on January 13, 2026, based on a 91-RCT meta-analysis (N=107,910) showing no increased risk. Serious and rare adverse events are covered on page 6.
Trial protocols
Concomitant interventions in each trial protocol
What each trial's protocol specified alongside the study drug. Obesity-indication trials typically included structured diet, exercise, and counseling in both treatment and placebo arms. SELECT, a cardiovascular outcomes trial, did not protocolize a lifestyle intervention.
| Trial | Diet prescription | Exercise prescription | Counseling | Frequency | Total sessions | Weight loss (ITT) |
|---|---|---|---|---|---|---|
| STEP 1, 2, 4, 5 | −500 kcal/day deficit | ≥150 min/week | Individual, in-person or phone | Every 4 weeks | ~17 sessions | −9.6% to −17.4% |
| STEP 3 | 1,000–1,200 kcal/day × 8 wk, then 1,200–1,800 | 100→200 min/wk (progressive) | Intensive behavioral therapy | >Weekly early on | 30 sessions | −16.0% |
| SURMOUNT-1, 2, 4 | −500 kcal/day (~1,200–1,500 kcal/day) | ≥150 min/week | Monthly counseling | ~Monthly | ~18 sessions | −14.7% to −25.3% |
| SURMOUNT-3 lead-in | 1,200–1,500 kcal/day | ≥150 min/week | ≥14 sessions in 12 weeks | Weekly+ during lead-in | 14+ in 12 wk | −18.4% |
| OASIS 1, 4 | −500 kcal/day deficit | ≥150 min/week | Lifestyle counseling | Periodic (likely monthly) | ~15–17 sessions | −13.6% to −15.1% |
| ATTAIN-1, 2 | "Healthy diet" counseling | Physical activity counseling | Counseling sessions | Periodic | Not specified | −9.6% to −11.1% |
| REDEFINE 1 | −500 kcal/day deficit | ≥150 min/week | Counseling sessions | Every 4 weeks | ~17 sessions | −20.4% |
| SELECT | No protocolized diet/exercise intervention — standard-of-care recommendations only. Study visits every 4–8 weeks. Weight loss (ITT): −10.2% | |||||
SELECT and STEP 1 comparison. Both trials used semaglutide 2.4 mg weekly. STEP 1 included ~17 structured counseling sessions over 68 weeks and reported −14.9% weight loss (ITT). SELECT included no protocolized lifestyle intervention and reported −10.2% weight loss at week 208 (ITT). The trials differ in population, duration, and primary endpoint, so the numbers are not a controlled comparison of lifestyle contribution; they are reported here as protocol-level reference points.
Representativeness
Trial populations vs. the US adult obesity population
Bessette & Anderson (JAMA Intern Med, 2025) applied the pivotal-trial entry criteria to nationally representative NHANES data (N=8,767, representing 110.3 million US adults with overweight or obesity). The figures below show what share of treatment-eligible adults would have been excluded from each trial program by its full entry criteria, and which common conditions were grounds for exclusion. Adults ≥60 years were disproportionately likely to meet exclusion criteria.
| Exclusion criterion | Applied in | Prevalence in US obese adults |
|---|---|---|
| Type 2 diabetes | All trials except T2D-specific arms | ~25–30% of adults with BMI ≥30 |
| Prior bariatric surgery | All trials | ~270,000 surgeries/year in US |
| Major depression ≤2 years | All trials (PHQ-9 ≥15) | ~8–10% of US adults; higher among obese |
| Anti-obesity meds within 90 days | All trials | Common (phentermine, other agents) |
| GI motility medications | SURMOUNT trials | 23.5% of eligible adults (PPIs, opioids, CCBs, TCAs) |
| Renal impairment (CKD 3+) | Most trials | ~15% of obese adults |
| Insulin therapy | SURMOUNT-2, ATTAIN-2 | ~30% of T2D patients |
Demographic composition of trial populations. STEP 1 enrolled 5% Black participants; the US obese population is 12.4% Black. SELECT enrolled 3.8% Black participants. Across 27 GLP-1 obesity RCTs, 65–73% of participants were female. In SELECT, women had greater weight loss than men (−11.1% vs. −7.5%). ICER rated the STEP and SURMOUNT trials as "Fair" for race/ethnicity diversity and "Fair to Poor" for sex representation.
Source: Bessette LG, Anderson TS. "Generalizability of Clinical Trials of Novel Weight Loss Medications to the US Adult Population." JAMA Intern Med 2025;185(1):108–110. DOI: 10.1001/jamainternmed.2024.6340.
Methodology
How this page was built
All data is drawn from peer-reviewed publications in NEJM, JAMA, Lancet, Nature Medicine, JAMA Internal Medicine, Diabetes Care, and related journals. DOIs are provided for every primary trial citation. Where trials report multiple estimands (on-treatment vs. treatment-policy), both are presented with the estimand clearly labeled. "Treatment-policy" and "ITT" are used interchangeably — both refer to the analysis that includes all randomized participants regardless of treatment discontinuation.
Responder threshold data uses the treatment-policy estimand where available; approximations are flagged in the table source notes. Phase 2 data is labeled and handled separately from Phase 3 pivotal-trial data. All trials were industry-funded by Novo Nordisk (STEP, OASIS, SCALE, SELECT, REDEFINE), Eli Lilly (SURMOUNT, ATTAIN, retatrutide), Boehringer Ingelheim/Zealand (survodutide), or Amgen (maritide).
This page presents the data as published and flags the systematic factors — estimand choice, lifestyle intervention, population selection, completion rates — that create differences between headline trial numbers and real-world employer outcomes. Corrections and updates can be submitted via the contact page.
References
Sources
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