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
Qualifiers
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
Treatments tested in this trial
- Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly
- Dose escalation to 2 mg semaglutide weekly then no semaglutide
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
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