ClinicalTrials.gg
RecruitingNCT07325500REINFORCEUpdated Feb 18, 2026

Incretin Microdosing for Cardiometabolic Health in People With HIV

A Phase 2 interventional study of Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly and Dose escalation to 2 mg semaglutide weekly then no semaglutide in Weight Gain, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Weight Gain

Keywords

  • semaglutide
  • HIV
  • obesity
03

In context

Weight Gain

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed 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
  • 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 and undergo all required study procedures

Exclusion criteria

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 vaccine, 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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 semaglutide microdosing at 0.5 mg weekly

  • Experimental
    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.

    Drug: Dose escalation to 2 mg semaglutide weekly then no semaglutide

Interventions

  • DrugDose 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.

  • DrugDose 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.

This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: from week 12 to week 60

Secondary outcomes

  1. Tolerability of semaglutide microdosing in participants as indicated by total number of serious adverse events (SAEs) and adverse events (AEs)

    Total number of serious adverse events (SAEs) and adverse events (AEs) will be reported.

    Time frame: From baseline through week 60

  2. Absolute change in weight

    Time frame: Baseline, 12 weeks, 60 weeks

  3. Percent change in weight

    Time frame: Baseline, 12 weeks, 60 weeks

  4. Absolute change in body mass index (BMI)

    Time frame: Baseline, 12 weeks, 60 weeks

  5. Percent change in body mass index (BMI)

    Time frame: Baseline, 12 weeks, 60 weeks

  6. Absolute change in minimum waist circumference

    Time frame: Baseline, 12 weeks, 60 weeks

  7. Percent change in minimum waist circumference

    Time frame: Baseline, 12 weeks, 60 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for May 2028, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2026
First posted
Jan 8, 2026
StartActual
Feb 12, 2026
Primary completionEst.
May 31, 2028
CompletionEst.
Jun 30, 2029
Last update
Feb 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07325500
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado Denver - Anschutz Medical Campus (UCD-AMC), Massachusetts General Hospital (MGH)
Responsible party
Jordan Elizabeth Lake (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 8, 2026
Start date
Feb 12, 2026
Primary completion
May 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Feb 18, 2026

Study contacts

Jordan E Lake, MD, MSc
Contact
Jordan.E.Lake@uth.tmc.edu
713-500-6767
Arezou S Akha
Contact
arezou.sadighiakha@uth.tmc.edu
713-500-5541
Jordan Lake, MD, MSc
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Semaglutide

Start the discussion