Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

Sponsor
University College Dublin
Study ID
NCT04174755
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Injectable Product — DRUG
    Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
  • Standard of care — BEHAVIORAL
    Diet and exercise advice for 40 weeks

Study Details

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.

Key Dates

Start date
Jun 22, 2022
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 0.25/0.5/1 mg plus standard of care
  • Other: Standard of care alone

Primary Outcome Measure

Changes in total body weight (in Kg) [ Time Frame: 28 weeks ]

Central Contacts

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