Retatrutide is a novel agonist targeting GIP, GLP-1, and glucagon receptors, currently being studied for its potential in treating obesity, type 2 diabetes, and related comorbidities. The TRIUMPH-2 trial, a phase 3 randomized controlled trial, aimed to assess the efficacy and safety of retatrutide in adults diagnosed with obesity and type 2 diabetes.
Study Overview
The trial was conducted across 92 medical and research centers in eight countries, enrolling adults aged 18 years and older with a body mass index (BMI) of 27 kg/m² or higher and a glycated hemoglobin (HbA1c) level between 6.5% and 10.5%. Participants had to be on stable treatment for type 2 diabetes for at least 90 days prior to screening and had a history of unsuccessful dietary weight loss attempts.
Participants were randomly assigned to receive weekly subcutaneous injections of either retatrutide at doses of 4 mg, 9 mg, or 12 mg, or a placebo. The primary endpoint was the percentage change in body weight from baseline to week 80, comparing the retatrutide groups to the placebo group.
Findings
The trial screened 2047 participants, with 1152 ultimately being randomly assigned to one of the treatment groups. The mean age of participants was 55.1 years, with a mean BMI of 38.2 kg/m² and a mean HbA1c of 7.71%. Notably, 84% of participants were on oral glucose-lowering medications at baseline.
Results indicated that at week 80, the mean percentage change in body weight was -11.9% for the 4 mg dose, -16.8% for the 9 mg dose, and -18.8% for the 12 mg dose, compared to -5.1% for the placebo group. This demonstrates a significant reduction in body weight for those receiving retatrutide compared to placebo.
What this study does not show
While the TRIUMPH-2 trial provides evidence of the efficacy of retatrutide in reducing body weight in adults with obesity and type 2 diabetes, it does not establish long-term safety or effectiveness beyond the 80-week study period.
Evidence scorecard
- Analytic validity: established
- Clinical validity: established
- Clinical utility: established
The evidence is based on a human randomized controlled trial.