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Semaglutide Microdosing for Weight Management in People with HIV

This study is looking at how well semaglutide (a medication often used for weight loss and diabetes) can help people living with HIV manage their weight. Specifically, it compares two groups: one group will continue with a low dose of semaglutide (microdosing) after an initial weight loss period, and the other group will stop semaglutide after the initial weight loss. The main goal is to see if microdosing semaglutide helps prevent weight regain. You may be able to join if you are an adult with HIV, have been on stable HIV medication for at least 24 weeks, have a controlled viral load, and have a BMI of 30 or higher (or 27 or higher with certain conditions). The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 30 participants. It compares two groups receiving semaglutide differently after an initial treatment period.
What's involved
Participants will receive semaglutide, starting at 0.25 mg weekly and increasing up to 2.0 mg weekly over 12 weeks. The study will measure weight regain from week 12 to week 60.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for weight regain from week 12 to week 60, which is a total of 48 weeks after the initial 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07325500

Incretin Microdosing for Cardiometabolic Health in People With HIV

Recruiting
PHASE2Ages 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~30 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weeklyDose escalation to 2 mg semaglutide weekly then no semaglutide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent weight regain from weeks 12-60 (microdosing period)
Measured over from week 12 to week 60

Conditions

Weight Gain

Explore related trials

HIV InfectionObesity

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jordan Lake, MD, MSc · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Jordan E Lake, MD, MSc
[email protected]
713-500-6767
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent weight regain from weeks 12-60 (microdosing period)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).