The objectives of this study are as follows: Primary Objective * To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy. Secondary Objectives * To evaluate the tolerability of semaglutide microdosing in adults with HIV. * To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60.
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGPercent weight regain from weeks 12-60 (microdosing period)
The percent weight regain from weeks 12-60 (microdosing period), calculated as the median within-person: change in weight (kg) from weeks 60-12 (microdosing period) divided by the change in weight (kg) from weeks 12-0 (dose escalation period).
Time frame: from week 12 to week 60
Tolerability of semaglutide microdosing in participants as indicated by total number of serious adverse events (SAEs) and adverse events (AEs)
Total number of serious adverse events (SAEs) and adverse events (AEs) will be reported.
Time frame: From baseline through week 60
Absolute change in weight
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in weight
Time frame: Baseline, 12 weeks, 60 weeks
Absolute change in body mass index (BMI)
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in body mass index (BMI)
Time frame: Baseline, 12 weeks, 60 weeks
Absolute change in minimum waist circumference
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in minimum waist circumference
Time frame: Baseline, 12 weeks, 60 weeks
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