Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

NCT04174755 | Recruiting DMC

• 1 other identifier: SWIFT Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.

Conditions

Obesity; HIV-1-infection

Keywords

obesity; HIV; weight loss; GLP-1 analogue; immune activation; viral reservoir; gut microbiome

Outcome Measures

Primary Outcomes (1)

• Changes in total body weight (in Kg)

  Between-group differences in percent change from baseline to week 28 in total body weight

  28 weeks

Secondary Outcomes (9)

• Proportion of subjects not achieving 5% weight loss from baseline to week 16

  16 weeks

• Changes in numbers and function of immune cell subsets

  40 weeks

• Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)

  40 weeks

• Changes in gut microbiome composition in stool samples

  40 weeks

• Changes in parameters of glucose metabolism in blood samples

  40 weeks

Study Arms (2)

Semaglutide 0.25/0.5/1 mg plus standard of care

EXPERIMENTAL

Drug: Semaglutide Injectable Product; Behavioral: Standard of care

Standard of care alone

OTHER

Behavioral: Standard of care

Interventions

Semaglutide Injectable Product DRUG

Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.

Also known as: Ozempic

Semaglutide 0.25/0.5/1 mg plus standard of care

Standard of care BEHAVIORAL

Diet and exercise advice for 40 weeks

Also known as: Diet and exercise

Semaglutide 0.25/0.5/1 mg plus standard of care; Standard of care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Dublin: lead
• University of Copenhagen: collaborator
• Rush University Medical Center: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Dublin, D07 R2WY, Ireland

RECRUITING

Related Publications (1)

• O'Sullivan L, Savinelli S, O'Hare S, Holden S, McHugh C, Mallon P, Doran P. An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT). Trials. 2022 Jan 17;23(1):50. doi: 10.1186/s13063-021-05979-y.

  PMID: 35039057 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

semaglutide; Standard of Care; Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Stefano Savinelli, MD

CONTACT

+3532215014; stefano.savinelli1@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Microbial Diseases

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 22, 2019
• Study Start: June 22, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)