Trial results

Retatrutide Phase 3 results

The numbers Lilly disclosed, reported with the duration, population and estimand that make them mean anything.

Lilly has disclosed positive topline results from five Phase 3 retatrutide trials. Weight loss ranged from about 11.5% to about 28.7% depending on the trial, dose and duration, against 2.1% to 4.0% on placebo. Four of the five readouts are sponsor-reported topline figures that have not yet been through peer review. One, TRANSCEND-T2D-1, was published in The Lancet in June 2026.

Before the numbers

These are averages from controlled trials in selected populations, most with a mean baseline BMI around 40. They describe what happened to groups of participants under study conditions. They are not a prediction about any individual, and nothing on this page is medical advice or a recommendation to seek this drug.

Why “estimand” appears next to every number

A weight-loss percentage on its own is close to meaningless, and the reason is boring but decisive. Trials report results under different estimands — formal definitions of what question the number answers.

The efficacy estimand answers: what happens to people who take the drug as directed for the full period. It excludes the effect of stopping early. The treatment-regimen estimand answers: what happens across everyone randomised, including those who discontinued. The second is always the smaller number, and it is usually closer to what happens outside a trial.

Headlines quote the first. Both are given below where Lilly disclosed both. In TRIUMPH-1 the gap is 28.3% against 25.0% — not enormous, but the kind of difference that quietly inflates every downstream comparison.

TRIUMPH-3

NCT05882045 · Disclosed July 23, 2026

Topline only
Population
Adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes
Duration
80 weeks
Baseline
Mean body weight 111.4 kg (245.6 lb); mean BMI 40.4

Body weight change — efficacy estimand

DosePercent changeKilogramsPounds
9 mg-21.6%-23.9-52.7
12 mg-22.6%-25.3-55.8
Placebo-3.2%-3.5-7.7

Cardiovascular events: Lilly reported that major adverse cardiovascular events occurred less frequently than anticipated in both the retatrutide and placebo arms. For the five-component composite, 44 events occurred on retatrutide (pooled) against 52 on placebo, a hazard ratio of 0.82 with a 95% confidence interval of 0.55 to 1.22. For the three-component composite, 27 against 23, a hazard ratio of 1.12 with a 95% confidence interval of 0.64 to 1.96. Both intervals cross 1.0, so this trial does not establish a cardiovascular benefit.

Discontinuation due to adverse events: 9.8% (9 mg) and 13.5% (12 mg), compared with 4.8% on placebo.

TRIUMPH-3 was powered for weight loss, not for cardiovascular outcomes. The dedicated outcomes trial, TRIUMPH-Outcomes, is not expected to complete before 2029.

Source:Lilly's triple agonist retatrutide successful in two additional Phase 3 obesity trials,Eli Lilly and Company, July 23, 2026.

TRIUMPH-2

NCT05929079 · Disclosed July 23, 2026

Topline only
Population
Adults with type 2 diabetes and obesity or overweight
Duration
80 weeks
Baseline
Mean body weight 106.4 kg (234.6 lb); mean BMI 38.2; mean A1C 7.7%

Body weight change — efficacy estimand

DosePercent changeKilogramsPounds
4 mg-12.7%-13.5-29.8
9 mg-19.1%-20.6-45.4
12 mg-20.8%-22.5-49.6
Placebo-4.0%-4.2-9.3

A1C: -1.4% (4 mg), -1.6% (9 mg) and -1.5% (12 mg), compared with -0.2% on placebo, from a baseline of 7.7%.

Discontinuation due to adverse events: 3.8% (4 mg), 11.6% (9 mg) and 7.7% (12 mg), compared with 4.9% on placebo.

Source:Lilly's triple agonist retatrutide successful in two additional Phase 3 obesity trials,Eli Lilly and Company, July 23, 2026.

TRIUMPH-1

NCT05929066 · Disclosed May 21, 2026

Topline only
Population
Adults with obesity or overweight and at least one weight-related comorbidity, without diabetes
Duration
80 weeks
Baseline
Mean body weight 112.7 kg (248.5 lb); mean BMI 40.0

Body weight change — efficacy estimand

DosePercent changeKilogramsPounds
4 mg-19.0%-21.4-47.2
9 mg-25.9%-29.2-64.4
12 mg-28.3%-31.9-70.3
Placebo-2.2%-2.5-5.5

Treatment-regimen estimand (everyone randomised, including those who stopped): -17.6% on 4 mg, -23.7% on 9 mg, -25.0% on 12 mg, -3.9% on Placebo.

Discontinuation due to adverse events: 4.1% (4 mg), 6.9% (9 mg) and 11.3% (12 mg), compared with 4.9% on placebo.

A pre-specified 104-week extension in 532 participants with a BMI of 35 or above reported up to -30.3% (-38.5 kg; -85.0 lb) on the 12 mg arm escalated to maximum tolerated dose.

Lilly stated that analyses of the two basket sub-studies, in knee osteoarthritis pain and in obstructive sleep apnea, were not included in this release.

Source:Lilly's triple agonist retatrutide delivered powerful weight loss in pivotal Phase 3 obesity trial,Eli Lilly and Company, May 21, 2026.

TRANSCEND-T2D-1

NCT06354660 · Disclosed March 19, 2026

Peer reviewed
Population
Adults with type 2 diabetes inadequately controlled on diet and exercise alone; mean diabetes duration 2.5 years
Duration
40 weeks
Baseline
Mean A1C 7.9%; mean body weight 96.9 kg (213.6 lb); mean BMI 35.8

Body weight change — efficacy estimand

DosePercent changeKilogramsPounds
4 mg-11.5%-11.1-24.5
9 mg-15.5%-15.1-33.3
12 mg-16.8%-16.6-36.6
Placebo-2.5%-2.8-6.2

A1C: -1.7% (4 mg), -2.0% (9 mg) and -1.9% (12 mg), compared with -0.8% on placebo, from a baseline of 7.9%.

Discontinuation due to adverse events: 2.2% (4 mg), 4.5% (9 mg) and 5.1% (12 mg), compared with 0.0% on placebo.

Source:Lilly's triple agonist retatrutide demonstrated significant A1C and weight reductions in Phase 3 type 2 diabetes trial,Eli Lilly and Company, March 19, 2026. Published: The Lancet 2026;407(10546):2402–2413. DOI 10.1016/S0140-6736(26)00967-0. PMID 42250575.

TRIUMPH-4

NCT05931367 · Disclosed December 11, 2025

Topline only
Population
Adults with obesity or overweight and knee osteoarthritis, without diabetes
Duration
68 weeks
Baseline
Mean body weight 112.7 kg (248.5 lb); mean BMI 40.4; mean WOMAC pain subscale 6.0 points

Body weight change — efficacy estimand

DosePercent changeKilogramsPounds
9 mg-26.4%-29.1-64.2
12 mg-28.7%-32.3-71.2
Placebo-2.1%-2.1-4.6

Pain: WOMAC pain subscale fell by 4.5 points on 9 mg and 4.4 points on 12 mg, against 2.4 points on placebo, from a baseline of 6.0 points. The percentage forms of these changes were post-hoc rather than pre-specified.

Discontinuation due to adverse events: 12.2% (9 mg) and 18.2% (12 mg), compared with 4.0% on placebo.

Dysesthesia — altered or uncomfortable skin sensation — was reported by 8.8% on 9 mg and 20.9% on 12 mg, against 0.7% on placebo.

Source:Lilly's triple agonist retatrutide delivered weight loss along with relief from osteoarthritis pain in first successful Phase 3 trial,Eli Lilly and Company, December 11, 2025.

Limitations that matter

Four of five are not peer reviewed

Four of these five readouts are topline results disclosed by Lilly and have not yet been fully evaluated in a peer-reviewed publication. Only TRANSCEND-T2D-1 has been published in a peer-reviewed journal. Press releases from Lilly have been unusually detailed and have included unflattering figures such as discontinuation and dysesthesia rates, which counts in their favour. They are still documents written and released by the company that makes the drug.

Tolerability is a real signal, not a footnote

Discontinuation because of adverse events reached 18.2% on the 12 mg arm in TRIUMPH-4 against 4.0% on placebo. Dysesthesia — altered or uncomfortable skin sensation — was reported by 20.9% on that arm against 0.7% on placebo. These rates rise with dose, and the highest weight-loss numbers come from the highest doses. Reporting the efficacy without the discontinuation rate describes a group of people who are not the same as the group that started.

No cardiovascular benefit has been shown

This is the claim most likely to be overstated. TRIUMPH-3 enrolled people with established cardiovascular disease and reported event counts, but the confidence intervals crossed 1.0 in both composites. The trial was powered for weight, not for outcomes. TRIUMPH-Outcomes is the trial designed to answer the question, and it is not expected to complete before 2029.

Trial populations are selected

Mean baseline BMI in the obesity trials was around 40, which is class 3 obesity. Participants were screened, monitored and supported in ways that do not resemble ordinary care. Results in a general population would be expected to differ.

Detailed results are still to come

Lilly has said detailed results from the TRIUMPH trials will be presented at medical meetings and published in peer-reviewed journals. Until then, what exists publicly is a summary chosen by the sponsor. When the full papers appear, this page will be updated and the change logged.

Questions

How much weight did people lose on retatrutide in Phase 3?

It depends on the trial, the dose, the duration and which estimand is used. In TRIUMPH-1, adults with obesity and no diabetes lost an average of 28.3% of body weight on the 12 mg dose at 80 weeks under the efficacy estimand, against 2.2% on placebo. In trials of people with type 2 diabetes the figures were lower. These are sponsor-reported topline numbers, not peer-reviewed results.

Have the Phase 3 retatrutide results been peer reviewed?

Only one of them. TRANSCEND-T2D-1 was published in The Lancet in June 2026. The four TRIUMPH readouts are topline results disclosed by Lilly and have not yet been fully evaluated in a peer-reviewed publication.

Does retatrutide reduce heart attacks and strokes?

That has not been established. In TRIUMPH-3 the confidence intervals around the cardiovascular event comparisons crossed 1.0, meaning no benefit was demonstrated. The trial designed to answer this question, TRIUMPH-Outcomes, is not expected to complete until 2029.