Obesity evidence dossier

Retatrutide

Best-in-class weight-loss potential if approved. The 104-week extension (30.3%) signals continued loss with longer exposure, but reflects a selected BMI>=35 completer subgroup in the 12-mg-to-MTD arm, so it is not directly comparable to the full 80-week estimand.

Eli LillyPhase 3Once-weekly injection
Weight loss score /10094
Comparison status68–84 wk data · includes treatment stops
EvidencePhase 3 · Sponsor disclosure
Follow-up80 weeks

Total weight loss

25.0%

TRIUMPH-1 · 12 mg · week 80 · Includes treatment stops

Placebo-adjusted

21.1%

Difference from placebo in the same study when reported.

Study context

GIP/GLP-1/glucagon triple agonist/Adults with obesity or overweight, without diabetes/2339 participants across the study/80-week endpoint

Baseline: See the source for enrollment criteria

Ranked result & calculation

TRIUMPH-1 · 12 mg · 80 weeks

Adults with obesity or overweight, without diabetes. 2,339 participants across the study (not this dose arm alone).

Includes treatment stops. Treatment-policy results estimate outcomes regardless of stopping treatment.

Average weight loss
25%
Placebo group
3.9% loss
Beyond placebo
21.1 percentage points (arm subtraction)
Stopped due to adverse events
Not verified for this result

Score: 70% × 95.0 total-loss points + 30% × 91.8 beyond-placebo points = 94/100, rounded. Conversion scales

Alternative analysis assuming continued treatment: 28.3% total loss. This is not the result used for the headline score. Alternative analysis source ↗

Lilly, TRIUMPH-1 ↗Phase 3 · Sponsor disclosure · Reviewed 2026-09-21

Evidence

Benchmark read

TRIUMPH-1: Includes treatment stops.

Diabetes data

Retatrutide is also being studied in people with type 2 diabetes; those weight-loss estimates should be interpreted separately from non-diabetic obesity trials.

Safety

Side effects and cautions

Discontinuation read

Adverse-event discontinuation has not been verified for this result.

Common side effects

Gastrointestinal events were the main tolerability issue; adverse-event discontinuation was 11.3% at 12 mg versus 4.9% with placebo.

Main cautions

Not approved. A US BLA submission is planned for Q1 2027. The 104-week extension result is a selected subgroup and should not be read as the overall effect.

Latest catalyst

Retatrutide Phase 3 TRIUMPH-1 shows 28.3% weight loss at 80 weeks; 30.3% in a 104-week extension

May 21, 2026

Lilly's retatrutide met the Phase 3 TRIUMPH-1 primary endpoint with 28.3% mean weight loss at 80 weeks on 12 mg (vs. 2.2% placebo), 25.9% on 9 mg, and 19.0% on 4 mg by the efficacy estimand. A prespecified extension in completers with baseline BMI ≥35 who tolerated assigned medication showed 30.3% mean weight loss at 104 weeks for the 12 mg-to-maximum-tolerated-dose group. Regulatory pathway, tolerability profile, and upcoming TRIUMPH trial readouts remain key factors for commercial positioning.

Linked clinical trials

Trials in the saddl3 obesity snapshot

Non-diabetic obesity studies are prioritized; diabetes and healthy-volunteer studies remain visible and labeled.

NCT06383390

Phase 3

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Eli Lilly and Company

Non-diabetic obesity

Active

Mar 24, 2026

NCT06859268

Phase 3

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Eli Lilly and Company

Non-diabetic obesity

Active

Mar 3, 2026

NCT05882045

Phase 3

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Eli Lilly and Company

Non-diabetic obesity

Active

Jul 23, 2025

NCT06662383

Phase 3

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Eli Lilly and Company

Non-diabetic obesity

Active

Apr 27, 2025

NCT05929066

Phase 3

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Eli Lilly and Company

Non-diabetic obesity

Active

Apr 18, 2025

NCT07035093

Phase 3

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Eli Lilly and Company

Non-diabetic obesity

Recruiting

Mar 24, 2026

NCT07232719

Phase 3

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

Eli Lilly and Company

Non-diabetic obesity

Recruiting

Mar 20, 2026

NCT05931367

Phase 3

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

Eli Lilly and Company

Non-diabetic obesity

Completed

Jan 21, 2026

NCT04881760

Phase 2

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Eli Lilly and Company

Non-diabetic obesity

Completed

Sep 13, 2023

NCT06313528

Phase 1

A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Eli Lilly and Company

Non-diabetic obesity

Completed

Sep 23, 2025

NCT06039826

Phase 1

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Eli Lilly and Company

Non-diabetic obesity

Completed

Jul 26, 2024

NCT05548231

Phase 1

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Eli Lilly and Company

Non-diabetic obesity

Completed

Aug 14, 2023

Back to obesity comparisonLilly, TRIUMPH-1Back to total weight loss
Retatrutide 25.0%