Canada: The investigational dual GIP/GLP-1 agonist survodutide demonstrated significant weight loss and improvements in glycaemic control among adults with obesity and type 2 diabetes in the phase III SYNCHRONIZE-2 trial, although tolerability remains a concern.

"At week 76, participants receiving survodutide 3.6 mg and 6 mg achieved mean weight reductions of 8.2% and 9.8%, respectively, compared with 3.9% with placebo. Weight loss of at least 5% was achieved by 57.6%, 64.5%, and 35.1% of participants, respectively," the researchers reported in
The New England Journal of Medicine.
Obesity and type 2 diabetes frequently occur together, and effective weight management can substantially influence metabolic health. Survodutide is an investigational glucagon receptor–GLP-1 receptor dual agonist being studied for its potential effects on body weight and glycaemic control.
Sean Wharton, McMaster University, Hamilton, ON, Canada, and colleagues conducted a multinational, double-blind, phase III trial among adults with type 2 diabetes and a body-mass index (BMI) of at least 27. Participants were randomly assigned in a 1:1:1 ratio to receive once-weekly subcutaneous survodutide at doses of 3.6 mg or 6 mg, or placebo.
The two primary outcomes were percentage change in body weight and achievement of at least 5% weight loss from baseline through week 76.
A total of 752 participants were included, with 250 assigned to the 3.6-mg group, 251 to the 6-mg group and 251 to placebo. The mean age was 55.7 years, mean BMI was 36.5, and 49.3% of participants were men.
Key findings included:
  • Mean body weight decreased by 8.2% with survodutide 3.6 mg and 9.8% with 6 mg, compared with 3.9% with placebo at week 76.
  • Weight loss of at least 5% occurred in 57.6% and 64.5% of participants receiving the 3.6-mg and 6-mg doses, respectively, versus 35.1% with placebo.
  • Glycated haemoglobin (HbA1c) declined by 0.9 percentage points with 3.6 mg and 0.8 percentage points with 6 mg, compared with a 0.2 percentage-point reduction with placebo.
  • Gastrointestinal adverse events were the most frequently reported side effects, occurring in 72.8% of participants receiving 3.6 mg, 77.7% receiving 6 mg, and 38.6% receiving placebo.
  • Gastrointestinal events were generally described as mild to moderate and transient.
The weight-loss analysis used a treatment-regimen estimand, assessing outcomes regardless of whether participants discontinued or interrupted the assigned treatment or used other anti-obesity therapies.
The findings showed that both survodutide doses produced significantly greater weight reduction than placebo among adults with obesity and type 2 diabetes. However, the higher frequency of gastrointestinal adverse events with survodutide highlights tolerability as an important consideration.
Overall, weekly survodutide at 3.6 mg or 6 mg was associated with significant reductions in body weight and HbA1c compared with placebo over 76 weeks in adults with obesity and type 2 diabetes.
Reference:
DOI: 10.1056/NEJMoa2607219
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Article Source : The New England Journal of Medicine

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Medha Baranwal

Medha Baranwal holds a Bachelor’s degree in Biomedical Sciences from the University of Delhi and a Master’s degree in Biotechnology from Amity University. Since May 2018, she has been contributing to Medical Dialogues, writing and editing medical news articles that translate complex research into clear, accessible information for healthcare professionals.

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