randomized_controlled_trial · 2023
Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial
Jastreboff AM, Kaplan LM, Frias JP, et al. · New England Journal of Medicine
moderateDOI · 10.1056/nejmoa2301972PMID · 37366315Trial · nct04881760Verified
Plain-English summary
Retatrutide produced large dose-dependent weight reductions over 48 weeks, but it was still investigational and gastrointestinal effects and increased heart rate required further study.
Population
Adults with obesity or overweight plus at least one weight-related condition, without diabetes
Sample size
338
Intervention
Retatrutide 1 mg to 12 mg subcutaneously once weekly versus placebo for 48 weeks
Outcomes measured
Percentage change in body weight|Weight-loss thresholds|Cardiometabolic measures|Safety and tolerability
Key findings
At 48 weeks, mean weight reduction reached 24.2 percent in the 12 mg group; gastrointestinal adverse events were most common and heart rate increased dose dependently.
Funding & disclosures
Funded by Eli Lilly; several authors were employees or reported financial relationships with the sponsor and other pharmaceutical companies.
Limitations
Phase 2 sample size and duration limit certainty about rare adverse events, long-term maintenance and clinical outcomes. The trial was industry funded.Risk of bias
Low to moderate — randomized and double-blind, with sponsor involvement in design, analysis and reporting.Citation
Jastreboff AM, Kaplan LM, Frias JP, et al. (2023). Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2301972
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