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GAINPCCONTROL

RecruitingPhase 4

Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy

GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Obesity / overweight, Oncology

Key I/E criterion

Male

Primary endpoints

Serious AEs (any)Discontinuation due to AEMeasure of Weight

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 IDNCT06908694
Org study ID5100

Timeline

Milestones

Study first posted2025-04-03actual
Study start2025-07-02actual
Last update posted2025-07-29actual
Primary completion2026-07-31estimated
Study completion2026-07-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

Have a physician diagnosis of PC
Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)
Elevated BMI

1. ≥30kg/m2 or

2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia

Exclusion criteria

Type 1 diabetes
Taking a GLP-1 RA
<18 years of age
History of pancreatitis
Personal or family history of medullary cancer of the thyroid
Multiple endocrine neoplasia type 2

Endpoints (11)

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
2
Renal / kidney
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Cardiovascular outcomes
1
Glycemic / diabetes
1
Other (unclassified)
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Number of Clinical Outcomes

Time frame:12 months

event count, event

componentsAll-cause death, All-cause hospitalization, T2DM prevention, Myocardial infarction (any), Stroke (any), Heart-failure hospitalization, Peripheral-artery outcome composite

Weight & body composition

2 endpoints
Primary/protocol endpoint/low confidence

Measure of Weight

Time frame:12 months

descriptive

Primary/protocol endpoint

Measure of Waist Circumference

Time frame:12 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Concentration of HbA1c

Time frame:12 months

concentration, descriptive

LOINC 4548-4

Renal / kidney

2 endpoints
Primary/protocol endpoint

Concentration of Creatinine

Time frame:12 months

concentration, descriptive

Primary/protocol endpoint

Calculation of estimated glomerular rate

Time frame:12 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Measure of Blood Pressure

Time frame:12 months

descriptive, improvement

Primary/protocol endpoint

Concentration of Lipids

Time frame:12 months

concentration, descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of Serious Adverse Events

Time frame:12 months

Serious AEs (any)

event count, event

Primary/protocol endpoint

Number of Adverse Events leading to Drug Discontinuation

Time frame:6 months

Discontinuation due to AE

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Concentration of PSA

Time frame:12 months

concentration, descriptive

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.