Lipids & metabolic liver disease
Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial
An erratum to this article was published (Lancet Diabetes Endocrinol, Apr 2025 ↗)
Primary result · Abdominal visceral adipose tissueResult — go to the resultβ −30.82 cm² 95% CI −50.13 to −11.51Authors' conclusion
Semaglutide holds promise as an effective treatment for HIV-associated lipohypertrophy. The potential risk of serious adverse events deserves further scrutiny in large trials in people with HIV.
Study context
- Population
- People with HIV aged ≥18 years with controlled HIV-1, BMI ≥25 kg/m² and lipohypertrophy, without T1D or T2D; single US site8 per group withdrew
- Participants
- 108 people
- Comparison
- Once-weekly SC semaglutide vs placebo for 32 weeks
- Semaglutiden = 54
- Placebon = 54reference
- Primary endpoint
- Changes in adipose tissue quantity by body compartment; primary outcome abdominal visceral adipose tissue
- Follow-up
- 32 weeks
Methodological detailsdouble-blind, placebo-controlled, phase 2b, single-centre
- Double-blind
- Placebo-controlled
- Phase 2b
- Single-centre
Primary result
Abdominal visceral adipose tissue
β
−30.82 cm²
95% CI −50.13 to −11.51
As reported in the abstract
Further findings
Abdominal subcutaneous adipose tissue · 32 weeks
- Decrease in abdominal subcutaneous adipose tissue (sex-adjusted multiplicative regression)
- β −42.01 cm², 95% CI −75.49 to −8.52; % change −11.2%
- Intention-to-treat
Total body fat · 32 weeks
- Decrease in total body fat (sex-adjusted multiplicative regression)
- natural logarithmic −0.21 kg, 95% CI −0.33 to −0.08; % change −18.9%
- Intention-to-treat
Safety
| Outcome | Absolute risk difference (95% CI) | |
|---|---|---|
| Possibly related or related adverse eventsIntention-to-treat | 0.1111 (−0.0727 to 0.2869) | |
| −0.200.20.4Difference (linear scale) |
- Possibly related or related adverse events — Semaglutide-related grade 4 elevated lipase
- 1
Possibly related or related adverse events
- Possibly related cholelithiasis (grades 1 and 2)
Original publication
Once-weekly semaglutide in people with HIV-associated lipohypertrophy: a randomised, double-blind, placebo-controlled phase 2b single-centre clinical trial. Lancet Diabetes Endocrinol. Published 1 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →