NCT07325500 · The University of Texas Health Science Center, Houston
Incretin Microdosing for Cardiometabolic Health in People With HIV
(REINFORCE)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly
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.
DRUG
Dose escalation to 2 mg semaglutide weekly then no semaglutide
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.
Primary outcome measures
Percent weight regain from weeks 12-60 (microdosing period)
Time frame: from week 12 to week 60
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration
- All participants must be willing and able to provide written informed consent and undergo all required study procedures
Exclusion criteria
- 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
- Active eating disorder
- Use of human growth hormone, tesamorelin or anabolic steroids \<12 weeks prior to entry, unless on a stable dose for \>24 weeks prior to entry, or plans to start any of these medications while on study
- Active, severe delayed gastric emptying
- Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
- Known retinopathy
- Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Untreated, poorly controlled or previously undiagnosed thyroid disease
- Chronic pancreatitis
- Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA)
- Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) \<0.5 or \>10 milli-international units per liter (mIU/L) at screening
- Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Pregnancy, nursing or plans for either during the study period
- Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period
- Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator
Where
- Houston, Texas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado Denver - Anschutz Medical Campus (UCD-AMC), Massachusetts General Hospital (MGH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations