Weight Gain study: Dose escalation to
Official title Incretin Microdosing for Cardiometabolic Health in People With HIV
ClinicalTrials.gov ID: NCT07325500
What this study is testing
What is Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly?
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly is an investigational medicine, given as a once-weekly injection under the skin, being studied as a potential treatment for weight gain.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a small dose of semaglutide can keep weight loss in people with HIV after they finish a weight‑loss program. It also looks at how safe and tolerable the small dose is.
- Who it's for
- You may be able to join if you have HIV and have lost weight with a semaglutide program and want to keep it down.
- What's involved
- You will take a tiny dose of semaglutide at home and have check‑ins with the study team. You will also have measurements of weight, waist size and BMI taken.
- Time commitment
- The study lasts about 12 weeks of initial treatment plus 48 weeks of microdosing, with regular visits for measurements and safety checks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Weight greater than or equal to 400 pounds [due to dual X-ray absorptiometry (DXA) machine limitations] or unexplained weight change greater than or...
- 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...
- 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 \ 24 weeks prior to entry, or plans to start any of these medications while on study
See the full eligibility 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
- 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 \ 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) \ 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
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.