Incretin Microdosing for Cardiometabolic Health in People With HIV
ConditionWeight Gain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed human immunodeficiency virus type 1 (HIV-1)
On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration
HIV-1 ribonucleic acid (RNA) <200 copies/mL at screening
BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if also with greater than or equal to 1 weight-related comorbidity
Disqualifiers
Weight greater than or equal to 400 pounds [due to dual X-ray absorptiometry (DXA) machine limitations] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry
Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded)
Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period
Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
Trial design
Design model
Parallel
Treatments tested in this trial
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly
DrugParticipants 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.
Dose escalation to 2 mg semaglutide weekly then no semaglutide
DrugParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weeklyExperimental treatment 1 intervention
Group B: Dose escalation to 2 mg semaglutide weekly then no semaglutideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent 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 60Secondary outcomes
1
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 602
Absolute change in weight
Time frame
Baseline, 12 weeks, 60 weeks3
Percent change in weight
Time frame
Baseline, 12 weeks, 60 weeks4
Absolute change in body mass index (BMI)
Time frame
Baseline, 12 weeks, 60 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)
Collaborator
Massachusetts General Hospital (MGH)
Collaborator
Source ClinicalTrials.gov