Weight GainPhase 2REINFORCENCT07325500
Incretin Microdosing for Cardiometabolic Health in People With HIV
A Phase 2 study testing 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 people with Weight Gain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Gain
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jordan E Lake, MD, MSc, 713-500-6767, Jordan.E.Lake@uth.tmc.edu
Arezou S Akha, 713-500-5541, arezou.sadighiakha@uth.tmc.edu
About this study
Official title: Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial
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.
- Conditions
- Weight Gain
- Being tested
- Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly, Dose escalation to 2 mg semaglutide weekly then no semaglutide
- Keywords
- semaglutide, HIV, obesity
- Medical subject headings
- Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weeklyDrug
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.
Dose escalation to 2 mg semaglutide weekly then no semaglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly | Experimental | 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. Receives: Drug: Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly |
| Dose escalation to 2 mg semaglutide weekly then no semaglutide | Experimental | 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. Receives: Drug: Dose escalation to 2 mg semaglutide weekly then no semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from week 12 to week 60
Secondary outcomes (7)
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.
Measured: From baseline through week 60
Absolute change in weight
Measured: Baseline, 12 weeks, 60 weeks
Percent change in weight
Measured: Baseline, 12 weeks, 60 weeks
Absolute change in body mass index (BMI)
Measured: Baseline, 12 weeks, 60 weeks
Percent change in body mass index (BMI)
Measured: Baseline, 12 weeks, 60 weeks
Absolute change in minimum waist circumference
Measured: Baseline, 12 weeks, 60 weeks
Percent change in minimum waist circumference
Measured: Baseline, 12 weeks, 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start12 Feb 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Massachusetts General Hospital (MGH)
- Responsible party
- Principal investigator, Jordan Elizabeth Lake, The University of Texas Health Science Center, Houston
- Investigators
- Jordan Lake, MD, MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325500
- Sponsor's protocol ID
- HSC-MS-25-0376
- Other IDs
- 1R01DK142171-01A1
- Acronym
- REINFORCE
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial
- ClinicalTrials.gov ID
- NCT07325500
- Acronym / sponsor ID
- REINFORCE / HSC-MS-25-0376
- Conditions
- Weight Gain
- Keywords
- semaglutide, HIV, obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver, Massachusetts General Hospital (MGH)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly | Experimental | Drug: Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weeklyParticipants 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. |
| Dose escalation to 2 mg semaglutide weekly then no semaglutide | Experimental | Drug: Dose escalation to 2 mg semaglutide weekly then no semaglutideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weeklyParticipants 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 |
| Dose escalation to 2 mg semaglutide weekly then no semaglutideParticipants 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 |
Primary outcome
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).
7 secondary outcomes
Tolerability of semaglutide microdosing in participants as indicated by total number of serious adverse events (SAEs) and adverse events (AEs)
Time frame: From baseline through week 60
Absolute change in weight
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in weight
Time frame: Baseline, 12 weeks, 60 weeks
Absolute change in body mass index (BMI)
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in body mass index (BMI)
Time frame: Baseline, 12 weeks, 60 weeks
Absolute change in minimum waist circumference
Time frame: Baseline, 12 weeks, 60 weeks
Percent change in minimum waist circumference
Time frame: Baseline, 12 weeks, 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Weight Gain
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Healthy Volunteers
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Lake, MD, MSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 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 people with Weight Gain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan E Lake, MD, MSc (713-500-6767, Jordan.E.Lake@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight regain from weeks 12-60 (microdosing period) (time frame: from week 12 to week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.