Retatrutide phase 2 shows up to 24.2% mean weight loss at 48 weeks

What was reported

Retatrutide phase 2 shows up to 24.2% mean weight loss at 48 weeks — a Clinical trial registry and conference presentation readout reported by Eli Lilly and Company on Jun 26, 2023. Linked to trial NCT05567796.

Related entities

Assets

Retatrutide

Companies

Eli Lilly

Design

Phase 2 dose-ranging study of retatrutide in adults with obesity, with 12-week and 48-week analyses.

Primary endpoint

Percent change in body weight from baseline

Result

Mean weight loss of 8.7% at 12 weeks and up to 24.2% at 48 weeks with retatrutide 12 mg.

Missing data

Efficacy estimand applied; missing data imputed under MAR assumptions.

Caveats

Phase 2 sample size; phase 3 TRIUMPH program will define confirmatory profile.

Comparison

Topline exceeded Lilly's prior expectations and triggered priority phase 3 investments.

Pipeline changes

Initiated global TRIUMPH phase 3 program and expanded NASH/cardiovascular plans.

Unknowns

Long-term safety, MACE outcomes, and durable weight maintenance pending phase 3.

Comparator

Placebo

Effect size

Retatrutide 12 mg vs placebo: -24.2% vs -2.1% at 48 weeks.

Discontinuations

Discontinuation due to adverse events was dose-related, highest at 12 mg.

Adverse events

GI events common; heart rate increases observed; no major safety signals identified.