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

What Was Tested

The trial (phase 2) is built around Tirzepatide and Semaglutide.

It had three arms (groups): Arm 1 (TRE) (experimental), Arm 2 (semaglutide, tirzepatide) (experimental) and Arm 3 (AHA HDD) (active comparator).

The registry classes the interventions as behavioral, drug, other, procedure and radiation.

More on the Plan

Characterize the metabolic and inflammatory profiles for patients at high risk of ADT-associated cardiometabolic disease during ADT.

Evaluate tolerability and feasibility of concurrently using GLP1-RA or performing TRE during short-term ADT.

Define the impact of metabolic interventions, including TRE and GLP1 RA treatment, on ADT-induced metabolome-inflammasome dysfunction.

Evaluate the impact of metabolic interventions, including TRE and GLP1 RA treatment, on clonal dynamics following ADT.

Who Took Part

60 planned participants were the target.

It was open to men only aged from 30 years up to 79 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Eastern Cooperative Oncology Group (ECOG) 0-2.

The full record lists 13 inclusion and 7 exclusion criteria; among the exclusions: currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet; currently under glp1-ra therapy; poorly controlled diabetes.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2025-11-05 with completion listed for 2028-04-09.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): 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). 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).

It also tracked 10 secondary outcomes, for example Changes in the 10-year risk of cardiovascular disease, Changes in visceral adiposity, Changes in muscle mass, Evidence of endothelial dysfunction, Percent of patients who successfully complete interventions and Quality of life - Sexual Health Inventory for Men.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide and Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.