Semaglutide’s Efficacy in Achieving Weight Loss for those with HIV

Phase 1

• Conditions: Human immunodeficiency virus (HIV) Infection and Obesity; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002314-39-IE
• Lead Sponsor: niversity College Dublin (UCD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Be over 18 years old
• Be HIV-1 antibody positive as determined by a positive 3rd or 4th generation Ag/Ab ELISA assay
• Be on stable ART for at least 2 years, with the last two viral loads <40
copies/mL or equivalent, based on local testing protocols
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Subjects unable to comply with the study protocol or unable to selfadminister
subcutaneous semaglutide
• History of obesity induced by other endocrine disorders: Cushing’s
syndrome, primary and secondary hypogonadism, hypothalamic disorders,
polycystic ovary syndrome, insulinoma
•Subjects with a diagnosis of diabetes mellitus who either have proliferative retinopathy or maculopathy requiring treatment or have not undergone retinal screening within the previous 12 months.
• History hypothyroidism that has recently been poorly-controlled, defined as
a TSH <0.5 mU/L or >10 mU/L within the last 12 months
• 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
• History of lipoatrophy or lipodystrophy, as per 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) coinfection
• 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 are 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
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified