Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: immune, other_emerging
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥27 required; conditions: Obesity; HIV-1-infection
- Interventions
- Semaglutide Injectable Product; Standard of care
- Conditions
- Obesity; HIV-1-infection
- Phase and size
- NA · 80 participants
- Dates
- Start 2022-06-22
Primary completion 2027-01 - Sponsor
- University College Dublin (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Changes in total body weight (in Kg)28 weeks
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.