Phase 3 Trials Ongoing

Retatrutide Clinical Trials

A detailed look at the TRIUMPH trial programme - what the Phase 2 results showed and what Phase 3 trials are currently investigating.

~24%

Max Phase 2 weight loss

~340

Phase 2 participants

48 weeks

Phase 2 duration

Understanding Trial Data

Phase 2 trials are designed to test different doses and gather preliminary efficacy data. They use relatively small numbers of participants. Phase 3 trials are larger, longer, and required for regulatory approval. Results from Phase 2 may not be replicated in Phase 3.

Phase 2 Trial Results (TRIUMPH-2)

Published in the New England Journal of Medicine in June 2023. This was a 48-week, randomised, double-blind, placebo-controlled trial.

Trial Details

Participants

~340 adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related condition

Duration

48 weeks of treatment with dose escalation over first 20-36 weeks

Doses Tested

1mg, 4mg, 8mg, 12mg weekly injections vs placebo

Primary Endpoint

Percentage change in body weight from baseline

Weight Loss by Dose

DoseWeight Loss~ParticipantsNotes
1 mg weekly~8%~70Lowest tested dose
4 mg weekly~17%~70Middle dose range
8 mg weekly~22%~70High efficacy dose
12 mg weekly~24%~70Highest tested dose
Placebo~2%~70Control group

Key findings: Weight loss was dose-dependent and continued throughout the 48-week period. Approximately 100% of participants on 8mg and 12mg doses achieved ≥5% weight loss. The majority of weight loss occurred during the first 24 weeks.

Read full study in NEJM

Current Phase 3 Trials

The TRIUMPH Phase 3 programme includes multiple trials. These larger studies will determine whether retatrutide can be approved for use.

TRIUMPH-1
Phase 3Ongoing
Type 2 Diabetes

Participants

~1,800

Duration

52 weeks

Focus

Evaluating glycemic control and safety in adults with type 2 diabetes

TRIUMPH-3
Phase 3Ongoing
Obesity/Overweight

Participants

~1,600

Duration

72 weeks

Focus

Evaluating weight loss efficacy and safety in adults with obesity

TRIUMPH-4
Phase 3Ongoing
Obesity/Overweight

Participants

~1,800

Duration

52 weeks

Focus

Long-term weight maintenance and cardiovascular outcomes

Interested in Joining a Trial?

Some trials may have UK sites. Search for eligibility at ClinicalTrials.gov or speak with your GP about trial opportunities.

How Do These Results Compare?

Retatrutide vs Tirzepatide (Mounjaro)

In separate Phase 2 trials, retatrutide (~24% at highest dose) appeared to show greater weight loss than tirzepatide (~21% at highest dose). However, cross-trial comparisons are unreliable.

Retatrutide vs Semaglutide (Wegovy)

Semaglutide trials showed ~15-17% weight loss over similar timeframes. Retatrutide's Phase 2 results suggest potentially greater efficacy, but Phase 3 confirmation is needed.

Important Caveats

Cross-trial comparisons are problematic because trials have different patient populations, inclusion criteria, study designs, and endpoints. The only reliable comparison would be a head-to-head trial, which hasn't been conducted.

Trial Programme Timeline

Phase 1 Trials

Completed 2022

Initial safety and dosing studies in healthy volunteers

Phase 2 Trials (TRIUMPH-2)

Completed 2023

Dose-finding study showing up to 24% weight loss over 48 weeks

Phase 3 Trials (TRIUMPH 1, 3, 4)

Ongoing 2024-2026

Large-scale trials for obesity and type 2 diabetes indications

Regulatory Submission

Expected 2026+

FDA and MHRA submissions expected if Phase 3 trials succeed

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Frequently Asked Questions

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice. Clinical trial data is preliminary and subject to change. Retatrutide is an investigational drug not approved by any regulatory authority. Individual results in trials varied significantly from averages presented. For advice about weight management treatments, consult a qualified healthcare provider.

Primary source: Jastreboff et al., NEJM 2023

Last updated: December 2025