Using Semaglutide to Help People with HIV Lose Weight
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
This study is testing if a weight loss medication called semaglutide can help people with HIV lose weight and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dublin, Dublin) |
| Trial ID | NCT04174755 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of semaglutide, a GLP-1 analogue, in promoting weight loss among obese individuals living with HIV. Participants will be randomly assigned to receive either semaglutide alongside lifestyle interventions or lifestyle interventions alone. The study aims to assess not only weight loss but also the impact of semaglutide on immune function, glucose and lipid metabolism, and gut microbiome in this population. The trial will include adults over 18 years old who are stable on antiretroviral therapy and meet specific BMI criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-1 positive adults aged 18 and older with a BMI of 30 or higher, or a BMI of 27 or higher with related health conditions.
Not a fit: Patients who have obesity due to endocrine disorders or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve weight management and overall health for individuals living with HIV who are struggling with obesity.
How similar studies have performed: While the use of semaglutide for weight loss is established, its specific application in obese individuals with HIV is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be over 18 years old * Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay * Be stable on ART with a viral load suppressed \<40 copies/mL for a minimum of 2 years * Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year * Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus * Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial Exclusion Criteria: * Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide * History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma * History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine). * Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin) * History of severe renal impairment, as defined by a baseline creatinine clearance \<30ml/min * Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment * Individuals with severe hepatic impairment (Child Pugh score \>9) * Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection * Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study * History of cancer (apart from treated Kaposi's Sarcoma) and/or receiving chemotherapy or radiotherapy * Active illicit intravenous drug use * Subjects concurrently enrolled in another clinical trial of an investigational medicinal product. * The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments * Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide * Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section) * For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
Where this trial is running
Dublin, Dublin
- Mater Misericordiae University Hospital — Dublin, Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Stefano Savinelli, MD
- Email: stefano.savinelli1@ucd.ie
- Phone: +3532215014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.