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SemVLCD

UnknownPhase 4

Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets

The Anabolic Effects of GLP-1 Agonism to Prevent Lean Muscle Losses During Very-low Calorie Diets (VLCDs) for Weight Loss

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

45

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥27

Primary endpoints

•Muscle protein synthesis rate•Muscle protein breakdown rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05606471
Org study ID21031

Timeline

Milestones

Study start2021-09-15actual
Study first posted2022-11-04actual
Last update posted2022-11-04actual
Primary completion2023-07-28estimated
Study completion2023-07-28estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Confirmed Type 2 Diabetes Mellitus
•Body mass index > 27kg·m-2
•Eligible for VLCD, Semaglutide (or both), within routine practice
•Ability to provide informed consent

Exclusion criteria

•BMI > 50kg·m-2
•Current pregnancy or breastfeeding, or intention to fall pregnant within the next 3 months
•Uncontrolled hypertension (blood pressure >200/120mmHg)
•Current treatment with insulin
•Current or recent use of GLP-1 agonists
•Previous adverse reaction to a GLP-1 agonist
•Current or recent involvement in a VLCD programme (within the last 12 months)
•History of >5% weight loss within the preceding 12 months
•Ingestion of exogenous D2O within the preceding 12 months
•Background of clinically significant cardiovascular, cerebrovascular or respiratory disease, neurological disorders or musculoskeletal problems
•History of malignancy undergoing current treatment or palliation
•History of any medical condition contraindicating the use of GLP-1 agonist medication
•Any other medical condition deemed by the investigators to preclude inclusion into the study

Endpoints (13)

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
9
Glycemic / diabetes
2
Other clinical outcomes
2

Weight & body composition

9 endpoints
Primary/protocol endpoint/low confidence

Muscle protein synthesis rate

Time frame:6 weeks

descriptive

Primary/protocol endpoint/low confidence

Muscle protein breakdown rate

Time frame:6 weeks

descriptive

Secondary/protocol endpoint

Skeletal muscle mass

Time frame:12 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Fat mass

Time frame:12 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Total body weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Skeletal muscle strength

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Right vastus lateralis muscle thickness

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Right vastus lateralis muscle cross sectional area (CSA)

Time frame:12 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Right vastus lateralis muscle fibre pennation angle

Time frame:12 weeks

change from baseline, descriptive

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Whole body insulin sensitivity

Time frame:12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Pancreatic beta cell function

Time frame:12 weeks

descriptive, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Skeletal neuromuscular function

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Gross skeletal muscle function

Time frame:12 weeks

descriptive, improvement

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 6, 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 6, 2026 snapshot.