Actively Recruiting
Incretin Microdosing for Cardiometabolic Health in People With HIV
Led by The University of Texas Health Science Center, Houston · Updated on 2026-02-18
30
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Incretin Microdosing for Cardiometabolic Health in People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed human immunodeficiency virus type 1 (HIV-1)
- On antiretroviral therapy for at least 24 weeks prior to entry with no changes in the last 12 weeks and no planned changes during the study
- HIV-1 RNA less than 200 copies/mL at screening
- Body mass index (BMI) of 30 kg/m2 or higher, or 27 kg/m2 or higher with at least one weight-related comorbidity
- Stable doses of anti-inflammatory or blood pressure, lipid, or glucose-lowering medications for at least 12 weeks prior to entry and no planned dose changes during the study
- Willing and able to provide written informed consent and complete all study procedures
You will not qualify if you...
- Weight of 400 pounds or more or unexplained weight change of 5% or more in the 12 weeks prior to entry
- Diagnosis or treatment for diabetes mellitus (stable metformin dosing for pre-diabetes allowed)
- Current or planned use of medications for obesity treatment or medications likely to cause significant weight change during the study
- Plans to start formal, intensive physical activity or diet programs such as ketogenic or very low carbohydrate diets during the study
- Active eating disorder
- Use of human growth hormone, tesamorelin, or anabolic steroids within 12 weeks prior to entry unless stable for more than 24 weeks, or plans to start these during the study
- Active, severe delayed gastric emptying
- Prior bariatric or major gastric surgery or plans for weight reduction surgery during the 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 or sensitivity to glucagon-like peptide-1 receptor agonists
- Poorly controlled or previously undiagnosed thyroid disease defined by thyroid-stimulating hormone levels below 0.5 or above 10 mIU/L at screening
- Active drug or alcohol use interfering with study adherence
- Pregnancy, nursing, or plans for either during the study
- Use or planned use of immunomodulatory therapy, HIV vaccine, investigational therapy, or tumor necrosis factor alpha therapy during the study
- Current serious illness requiring systemic treatment or hospitalization as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jordan E Lake, MD, MSc
CONTACT
A
Arezou S Akha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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