Study summary · research use only
Subgroup analysis by sex and baseline BMI in people with a BMI ≥27 kg/m(2) in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This phase 2 human trial (387 participants aged 18-75 years with a BMI ≥27 kg/m2, without diabetes) examined whether sex and baseline BMI influenced outcomes of once-weekly subcutaneous survodutide (0.6, 2.4, 3.6 or 4.8 mg) versus placebo over 46 weeks. After 46 weeks, females had greater reductions in bodyweight and waist circumference than males, and participants with lower baseline BMI had greater proportional bodyweight reduction, while the trend reversed for waist circumference. Adverse event rates were similar across sex and BMI subgroups, with nausea the most common gastrointestinal adverse event in all subgroups. The abstract reports that survodutide was associated with reductions in bodyweight and waist circumference compared with placebo across these subgroups.
Abstract
To explore the effects of sex and baseline body mass index (BMI) on the efficacy and safety of survodutide in people with a BMI ≥27 kg/m2. Totally 387 people (aged 18-75 years, BMI ≥27 kg/m2, without diabetes) were randomized 1:1:1:1:1 to once-weekly subcutaneous survodutide (0.6, 2.4, 3.6 or 4.8 mg) or placebo for 46 weeks (20-week dose escalation; 26-week dose maintenance). Participants were categorized according to sex and baseline BMI. Data were analysed descriptively for the full analysis set (FAS), according to dose assigned at randomization (planned treatment) using on-treatment data or all data censored for COVID-19-related treatment discontinuations. (ClinicalTrials.gov number: NCT04667377). After 46 weeks of survodutide treatment, females had greater reductions in bodyweight and waist circumference than males. Participants with a lower baseline BMI had greater proportional reductions in bodyweight than those with a higher baseline BMI; the trend was reversed for reductions in waist circumference. Rates of adverse events (AEs) were comparable between subgroups for sex and baseline BMI. Nausea was the most frequently reported gastrointestinal AE in all subgroups. In people with a BMI ≥27 kg/m2, survodutide was associated with clinically meaningful reductions in bodyweight and waist circumference when compared with placebo, in prespecified subgroups based on sex and baseline BMI, and was tolerated at all doses tested.
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