A Growth Differentiation Factor 15 Receptor Agonist in Randomized Placebo-Controlled Trials in Healthy or Obese Persons
Authors' conclusion
The prolonged half-life of MBL949 supports biweekly dosing in patients. MBL949 had an acceptable safety profile. The robust weight loss observed in nonclinical species did not translate to weight loss efficacy in humans.
Study context
- Population
- Overweight and obese healthy volunteers (phase 1); obese participants (phase 2)phase 1 n = 65
- Comparison
- MBL949 vs placebo
Methodological detailsplacebo-controlled, phase 1 first-in-human single ascending dose
- Placebo-controlled
- Phase 1 first-in-human single ascending dose
Primary result
As reported in the abstract
Weight loss · 14 weeks (phase 2)
- Phase 2: weight loss was minimal following biweekly dosing of MBL949 for 14 weeks
- Phase 1: evidence of weight loss at the higher doses
Further findings
Pharmacokinetics (phase 1)
- Mean terminal half-life
- 18 to 22 days
Nonclinical species
- Generally safe and effective, with reduced food intake and body weight in mice, rats, dogs and monkeys; weight loss primarily from reduced fat; metabolic endpoints improved
Safety
- MBL949 was safe and generally tolerated over the dose range tested; gastrointestinal adverse events were the most frequent
Original publication
A Growth Differentiation Factor 15 Receptor Agonist in Randomized Placebo-Controlled Trials in Healthy or Obese Persons. J Clin Endocrinol Metab. Published 16 August 2024. doi:10.
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