NCT07325500 Incretin Microdosing for Cardiometabolic Health in People With HIV
| NCT ID | NCT07325500 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Weight Gain |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-02-12 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jordan Lake, MD, MSc
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT07325500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Weight Gain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07325500 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07325500 currently recruiting?
Yes, NCT07325500 is actively recruiting participants. Contact the research team at Jordan.E.Lake@uth.tmc.edu for enrollment information.
Where is the NCT07325500 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07325500 clinical trial?
NCT07325500 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Jordan Lake, MD, MSc at The University of Texas Health Science Center, Houston. The trial plans to enroll 30 participants.