Retatrutide Clinical Trials

Retatrutide (LY3437943) is studied in three Phase 3 programs: TRIUMPH (obesity), TRANSCEND (type 2 diabetes) and SYNERGY (MASLD/MASH). All four TRIUMPH obesity trials have reported, with up to 28.3% weight loss at 80 weeks, and TRIUMPH-1 and TRIUMPH-2 were published in the New England Journal of Medicine and The Lancet in September 2026. Some studies are still recruiting: find a trial site near you.

Development Program Overview

For a narrative walk-through of the Phase 3 programs see TRIUMPH, TRANSCEND and SYNERGY explained; for a sortable table of every registered trial see the clinical trial tracker; to see which studies are still enrolling and where, use Find a Trial.

Eli Lilly's retatrutide program spans three Phase 3 families: TRIUMPH (obesity/weight management), TRANSCEND (type 2 diabetes), and SYNERGY (MASLD/MASH liver disease). TRIUMPH-4 delivered the first Phase 3 readout in December 2025, showing 28.7% weight loss at 12 mg/68 weeks. All five pivotal readouts had reported by July 2026, the head-to-head TRANSCEND-T2D-2 trial against semaglutide reported in October 2026, and Lilly says it plans to file for approval no later than the first quarter of 2027.

17
Total Trials
14
Completed
3
Ongoing
24,053
Total Enrolled

Development Timeline

Mar 2019
First-in-Human Study (Phase 1)
Retatrutide's first human study began in 2019 and showed a half-life of about 6 days, allowing weekly dosing. Design, sa...
Completed
Dec 2019
Phase 1b MAD Trial (Phase 1)
Phase 1b trial (NCT04143802) in adults with type 2 diabetes: rising weekly doses of retatrutide vs placebo, testing safe...
Completed
May 2021
Phase 2 Type 2 Diabetes Trial (Phase 2)
Phase 2 trial (NCT04867785, 281 adults): A1C fell up to 2.02 points at 24 weeks and weight up to 16.9% at 36 weeks on 12...
Completed
May 2021
Phase 2 MASLD Substudy (Phase 2)
A planned substudy of the Phase 2 obesity trial that measured liver fat by MRI in people with fatty liver disease (MASLD...
Completed
May 2021
Phase 2 Obesity Trial (Phase 2)
In the Phase 2 obesity trial (n=338), retatrutide produced up to -24.2% mean weight loss at 12 mg over 48 weeks. The hea...
Completed
May 2021
Phase 1 Japan Study (Phase 1)
A Phase 1 multiple-dose study (NCT04823208) of retatrutide's safety, blood levels and effects in Japanese adults with ty...
Completed
Jun 2023
Phase 2 Obesity Results Published (NEJM)
Jastreboff et al. report 24.2% weight loss at 12 mg/48 weeks, a record for any pharmaceutical agent in Phase 2.
Completed
Jun 2023
Phase 2 T2D Results Published (Lancet)
Rosenstock et al. report HbA1c reduction of -2.02% at 12 mg/36 weeks with 16.9% weight loss.
Completed
Jul 2023
Phase 2 CKD Trial (Phase 2)
A Phase 2 trial (NCT05936151) of retatrutide in adults with chronic kidney disease and overweight or obesity, looking at...
Completed
Aug 2023
TRIUMPH-4 (Phase 3)
The first Phase 3 retatrutide trial to report: 28.7% weight loss at 12 mg over 68 weeks and knee pain (WOMAC) down as mu...
Completed
Oct 2023
TRIUMPH-1 (Phase 3)
Retatrutide's main Phase 3 obesity trial (2,339 adults, 80 weeks): 28.3% average weight loss at 12 mg. Published in NEJM...
Completed
Nov 2023
TRIUMPH-2 (Phase 3)
Phase 3, 1,152 adults, 80 weeks. Topline July 23, 2026: -20.8% weight loss and A1C -1.5 points at 12 mg vs -4.0% and -0....
Completed
Jan 2024
TRANSCEND-T2D-1 (Phase 3)
Phase 3 trial of retatrutide in 537 adults with type 2 diabetes, published in The Lancet in June 2026: A1C down 1.94 poi...
Completed
Feb 2024
TRIUMPH-3 (Phase 3)
Phase 3, 1,949 adults with BMI 35+ and CVD, 80 weeks: -22.6% weight loss at 12 mg vs -3.2%, triglycerides -37%, hsCRP -5...
Completed
Mar 2024
TRANSCEND-T2D-2 (Phase 3)
First head-to-head trial vs semaglutide 2 mg (Ozempic), 1,298 adults with type 2 diabetes: A1C down 2.2 vs 1.8 points, w...
Completed
Apr 2024
TRIUMPH-Outcomes (Phase 3)
A large, still-running trial testing whether retatrutide lowers heart attacks, strokes and heart deaths in adults with o...
Ongoing
Jun 2024
MASLD Substudy Published (Nature Medicine)
Sanyal et al. report 82% liver fat reduction, the most potent pharmacological liver fat reduction ever reported.
Completed
Sep 2024
EMA Pediatric Investigation Plan Agreed
European Medicines Agency agrees on pediatric investigation plan for retatrutide in adolescents aged 12-17.
Completed
Dec 2025
TRIUMPH-4 Phase 3 Results Reported
First Phase 3 readout: 28.7% weight loss at 12 mg/68 weeks in obesity with knee OA. New dysesthesia signal identified.
Completed
Jan 2026
TRIUMPH-9 (Dose Escalation Optimization) (Phase 3)
Investigating different retatrutide dose escalation schemes to optimize efficacy-tolerability balance.
Ongoing
Mar 2026
TRANSCEND-T2D-1 Results Reported
Type 2 diabetes: HbA1c down 1.94 points and weight down 15.3% at 12 mg over 40 weeks; published in The Lancet June 6, 2026.
Completed
May 2026
TRIUMPH-1 Results Reported
Pivotal obesity trial: 28.3% weight loss at 12 mg over 80 weeks in 2,339 adults; published in NEJM September 29, 2026.
Completed
Jul 2026
TRIUMPH-2 and TRIUMPH-3 Results Reported
Obesity with type 2 diabetes (-20.8%) and severe obesity with cardiovascular disease (-22.6%) at 12 mg over 80 weeks.
Completed
Oct 2026
FDA Classification Ruling
The FDA ruled that retatrutide is a drug, so the application must be a New Drug Application (NDA); Lilly disputes this in court.
Completed
Oct 2026
TRANSCEND-T2D-2 Topline Results
Head-to-head vs semaglutide 2 mg: A1C -2.2 vs -1.8 points; weight -20.9% (12 mg) vs -9.4% at 80 weeks. Not yet peer reviewed.
Completed
By Q1 2027
Application for Approval Planned
Lilly says it plans to file no later than Q1 2027 and has not said which pathway it will use; the FDA says it must be an NDA.
Planned
Late 2027-2028
Potential FDA Approval Decision
Our estimate: late 2027 with priority review, around Q1 2028 with standard review.
Planned
2029-30
CVOT & Liver Outcomes Results
TRIUMPH-Outcomes (~10,000 pts, CV events) and SYNERGY-Outcomes (~4,500 pts, liver outcomes); ClinicalTrials.gov estimates primary completion in 2029 and 2030.
Planned

All Trials

Results Published 3

TRIUMPH-1

TRIUMPH-1: Phase 3 Pivotal Obesity Trial of Retatrutide (Results-Published)

Retatrutide's main Phase 3 obesity trial (2,339 adults, 80 weeks): 28.3% average weight loss at 12 mg. Published in NEJM, September 2026.

2,339 participants View details
Ongoing 3

TRIUMPH-9 (Dose Escalation Optimization)

Phase 3b Dosing Optimization Study for Retatrutide

Investigating different retatrutide dose escalation schemes to optimize efficacy-tolerability balance.

600 participants View details
Recruiting 3

SYNERGY-OUTCOMES

SYNERGY-OUTCOMES Trial: Retatrutide for Liver Disease (MASH)

SYNERGY-OUTCOMES is a Phase 3 trial testing retatrutide and tirzepatide against placebo for preventing serious liver events in high-risk MASLD/MASH.

4,500 participants View details
Results Published 3

TRANSCEND-T2D-2

TRANSCEND-T2D-2: Retatrutide vs Semaglutide

First head-to-head trial vs semaglutide 2 mg (Ozempic), 1,298 adults with type 2 diabetes: A1C down 2.2 vs 1.8 points, weight down up to 20.9% vs 9.4%.

1,298 participants View details
Results Published 3

TRIUMPH-4

TRIUMPH-4: Obesity with Knee Osteoarthritis (First Phase 3 Readout)

The first Phase 3 retatrutide trial to report: 28.7% weight loss at 12 mg over 68 weeks and knee pain (WOMAC) down as much as 75.8% in obesity with knee OA.

445 participants View details
Completed 1

Phase 1 Japan Study

Phase 1 Study in Japanese Subjects (NCT04823208)

A Phase 1 multiple-dose study (NCT04823208) of retatrutide's safety, blood levels and effects in Japanese adults with type 2 diabetes.

64 participants View details
Results Published 2

Phase 2 Body Composition Substudy

Phase 2 Body Composition Substudy

DXA scans from the Phase 2 type 2 diabetes trial: fat mass fell 26.1% on 8 mg and 23.2% on 12 mg at 36 weeks, vs 4.5% on placebo.

189 participants View details
Completed 2

Phase 2 CKD Trial

Phase 2 Chronic Kidney Disease Trial (NCT05936151)

A Phase 2 trial (NCT05936151) of retatrutide in adults with chronic kidney disease and overweight or obesity, looking at kidney function and weight.

146 participants View details
Results Published 2

Phase 2 MASLD Substudy

Phase 2 MASLD/MASH Substudy (Liver Fat Analysis)

A planned substudy of the Phase 2 obesity trial that measured liver fat by MRI in people with fatty liver disease (MASLD). Results and what they mean.

98 participants View details
Results Published 3

TRANSCEND-T2D-1

TRANSCEND-T2D-1: Phase 3 Type 2 Diabetes Trial (Results-Published)

Phase 3 trial of retatrutide in 537 adults with type 2 diabetes, published in The Lancet in June 2026: A1C down 1.94 points and weight down 15.3% at 12 mg.

537 participants View details
Results Published 3

TRIUMPH-3

TRIUMPH-3: Retatrutide in Severe Obesity With Cardiovascular Disease

Phase 3, 1,949 adults with BMI 35+ and CVD, 80 weeks: -22.6% weight loss at 12 mg vs -3.2%, triglycerides -37%, hsCRP -51%; MACE-5 HR 0.82, not significant.

1,949 participants View details
Ongoing 3

TRIUMPH-Outcomes

TRIUMPH-Outcomes: Cardiovascular Outcomes Trial (CVOT)

A large, still-running trial testing whether retatrutide lowers heart attacks, strokes and heart deaths in adults with obesity and cardiovascular disease.

10,000 participants View details
Results Published 3

TRIUMPH-2

TRIUMPH-2: Retatrutide in Obesity With Type 2 Diabetes (Results)

Phase 3, 1,152 adults, 80 weeks. Topline July 23, 2026: -20.8% weight loss and A1C -1.5 points at 12 mg vs -4.0% and -0.2 on placebo; dysesthesia 7.3%.

1,152 participants View details
Results Published 2

Phase 2 Type 2 Diabetes Trial

Phase 2 Type 2 Diabetes Trial of Retatrutide (NCT04867785)

Phase 2 trial (NCT04867785, 281 adults): A1C fell up to 2.02 points at 24 weeks and weight up to 16.9% at 36 weeks on 12 mg, vs placebo and dulaglutide.

281 participants View details
Results Published 1

Phase 1b MAD Trial

Phase 1b Multiple Ascending Dose Trial (NCT04143802)

Phase 1b trial (NCT04143802) in adults with type 2 diabetes: rising weekly doses of retatrutide vs placebo, testing safety, blood levels and glucose effects.

72 participants View details
Results Published 2

Phase 2 Obesity Trial

Retatrutide Phase 2 Obesity Trial: -24.2% Weight Loss

In the Phase 2 obesity trial (n=338), retatrutide produced up to -24.2% mean weight loss at 12 mg over 48 weeks. The headline result, doses, and safety data.

338 participants View details
Completed 1

First-in-Human Study

Retatrutide Phase 1 Trial: First Human Study (2019)

Retatrutide's first human study began in 2019 and showed a half-life of about 6 days, allowing weekly dosing. Design, safety and early results.

45 participants View details