GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT07202247

RecruitingPhase 2

Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial

A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)

Lead sponsor

City of Hope Medical Center

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Oncology

Key I/E criteria

•BMI ≥30•Male

Primary endpoint

•Changes in the 10-year risk of cardiovascular disease

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 IDNCT07202247

Org study ID25332

Secondary IDNCI-2025-06197CTRP (Clinical Trial Reporting Program)

Secondary IDP30CA033572

Timeline

Milestones

Study first posted2025-10-01actual

Study start2026-01-23actual

Last update posted2026-02-04actual

Primary completion2028-04-09estimated

Study completion2028-04-09estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age30 Years

Maximum age79 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Documented informed consent of the participant

•English, Spanish or Mandarin-speaking

•Agreement to allow the use of archival tissue from diagnostic tumor biopsies

–If unavailable, exceptions may be granted with study principal investigator (PI) approval

•Male

•Aged: 30-79

•Eastern Cooperative Oncology Group (ECOG) 0-2

•High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as:

–Body mass index (BMI) of ≥ 30 kg/m^2 or

–BMI ≥ 27 kg/m^2 in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia)

•Prostate cancer defined as one of the following:

–National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months

–Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months

Exclusion criteria

•Currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet

•Currently under GLP1-RA therapy

•Poorly controlled diabetes

•Unable to undergo time-restricted diet

•Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease

•Other active disease deemed not eligible to participant in the study according to treating physician

•Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Endpoints (12)

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

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Changes in visceral adiposity

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in muscle mass

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

Lean mass

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Primary/protocol endpoint

Changes in the 10-year risk of cardiovascular disease

Time frame:At completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT

change from baseline, improvement

Primary/protocol endpoint

Changes in the 10-year risk of cardiovascular disease

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

change from baseline, improvement

Secondary/protocol endpoint

Changes in the 10-year risk of cardiovascular disease

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

change from baseline, improvement

Secondary/protocol endpoint

Evidence of endothelial dysfunction

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

descriptive

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint/low confidence

Quality of life - International Prognostic Scoring System

Time frame:At baseline and up to 12 months after completion of ADT

descriptive

Secondary/protocol endpoint

Quality of life - Sexual Health Inventory for Men

Time frame:At baseline and up to 12 months after completion of ADT

descriptive

Secondary/protocol endpoint

Quality of life - Merrick rectal function

Time frame:At baseline and up to 12 months after completion of ADT

descriptive, improvement

Secondary/protocol endpoint

Quality of life - Patient Reported Outcomes Measurement Information System 29

Time frame:At baseline and up to 12 months after completion of ADT

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percent of patients who successfully complete interventions

Time frame:Up to 12 months after completion of ADT

threshold achievement, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Incidence of de novo metabolic syndrome

Time frame:At completion of 6 months of ADT and at 12 months follow up after completion of ADT

threshold achievement, event

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.