Semaglutide microdosing for weight control in people living with HIV
Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial
Small weekly doses of semaglutide will be tried to see if they prevent weight regain in adults living with HIV after an initial weight-loss induction.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07325500 on ClinicalTrials.gov |
What this trial studies
Adults with HIV on stable antiretroviral therapy and with obesity will complete a 12-week semaglutide induction with dose escalation up to 2 mg weekly. After induction, participants are assigned to continued semaglutide microdosing (0.5 mg weekly) or no additional semaglutide for 48 weeks, with regular visits to track weight, waist circumference, BMI and tolerability. The primary outcome is the rate of weight regain after induction; secondary outcomes include tolerability and changes in body composition over the 60-week period. The trial is led by The University of Texas Health Science Center at Houston with collaboration from NIDDK, University of Colorado Denver Anschutz, and Massachusetts General Hospital.
Who should consider this trial
Good fit: Adults living with HIV who are on stable ART with viral suppression and have BMI ≥30 kg/m2 (or ≥27 kg/m2 with a weight-related comorbidity) and can attend in-person visits are the intended candidates.
Not a fit: People with uncontrolled HIV, recent unexplained weight change, weight ≥400 pounds (DXA limit), recent ART changes, or those unable to maintain stable concomitant medications or attend study visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help people living with HIV keep off weight after initial weight loss and improve long-term cardiometabolic health.
How similar studies have performed: Large semaglutide trials in the general population have shown substantial weight loss, but the strategy of low-dose maintenance to prevent regain in people with HIV is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jordan Lake, MD, MSc — The University of Texas Health Science Center, Houston
- Study coordinator: Jordan E Lake, MD, MSc
- Email: Jordan.E.Lake@uth.tmc.edu
- Phone: 713-500-6767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.