DelfaGLP-1 Atlas

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SWIFT

RecruitingPhase NA

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

HIV, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04174755
Org study IDSWIFT Study

Timeline

Milestones

Study first posted2019-11-22actual
Study start2022-06-22actual
Last update posted2026-04-29actual
Primary completion2027-01estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

HIVObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Other (unclassified)
3
Glycemic / diabetes
1
MASH / liver
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Changes in total body weight (in Kg)

Time frame:28 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Changes in bone mineral density (BMD) and total body composition

Time frame:40 weeks

percent change from baseline, improvement

componentsTotal fat mass, Lean mass

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Changes in parameters of glucose metabolism in blood samples

Time frame:40 weeks

percent change from baseline, improvement

componentsFasting glucose, change, HbA1c, % change

MASH / liver

1 endpoint
Secondary/protocol endpoint

Changes in liver stiffness

Time frame:40 weeks

Liver stiffness (VCTE), change

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in parameters of lipid metabolism

Time frame:40 weeks

percent change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Proportion of subjects reporting any adverse event

Time frame:40 weeks

Treatment-emergent AEs (any)

threshold achievement, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Changes in numbers and function of immune cell subsets

Time frame:40 weeks

percent change from baseline, descriptive

componentsNK cells, MAIT cells, T-cells, Monocytes

Secondary/protocol endpoint/low confidence

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

Time frame:40 weeks

percent change from baseline, descriptive

componentshiv proviral dna pbmcs, cell associated rna ca rna pbmcs

Secondary/protocol endpoint/low confidence

Changes in gut microbiome composition in stool samples

Time frame:40 weeks

percent change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.