Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.
Level 5 - mechanism / opinion, no new human data
Trial design and baseline characteristics paper without comparative outcome data
PubMed 32441473 · doi:10.1002/oby.22794
What was done
Described the design and baseline demographics for five phase 3 randomized trials (STEP 1 to 5: NCT03548935, NCT03552757, NCT03611582, NCT03548987, NCT03693430) evaluating once-weekly subcutaneous semaglutide 2.4 mg versus placebo as an adjunct to lifestyle interventions for weight management in adults with overweight or obesity, with or without type 2 diabetes. The primary outcome for all trials is change in body weight from baseline to end of treatment.
What was found
Across the five trials (~5,000 participants total), participants had a mean age ranging from 46.2 to 55.3 years, were predominantly female (74.1% to 81.0%), had a mean baseline BMI of 35.7 to 38.5 kg/m², and a mean waist circumference of 113.0 to 115.7 cm. No efficacy or safety results were reported.
Why it matters
Establishes the clinical rationale, trial designs, and baseline demographic characteristics for the registration program of semaglutide 2.4 mg for chronic weight management.
Limits
This is a trial protocol and baseline descriptive report containing no outcome data on weight loss, safety, or tolerability. Participants across trials are heavily skewed female (over 74%), which may limit generalizability to male populations.
Cited by
- supports The highest available standard dose of semaglutide is 2.4 milligrams.