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Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Plain-language guide to NCT06759701: early phase 1 interventional trial of Tirzepatide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06759701
- Phase
- early phase 1
- Status
- recruiting participants
- Start
- 2025-07-02
- Completion (planned or actual)
- 2026-12-31
- Participants
- 30 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Tirzepatide.
It had 1 arm (groups): Tirzepatide (experimental).
The registry classes the interventions as drug.
More on the Plan
Determine differences in plasma and tumor sphingolipids following tirzepatide-based intervention 2.
Determine differences in markers of insulin and insulin signaling following tirzepatide-based intervention 3.
Determine differences in prostate, plasma and periprostatic fat inflammatory signaling following tirzepatide-based intervention 4.
Determine differences in ASCVD risk factors following tirzepatide-based intervention. 6.
Who Took Part
The registry lists 30 planned participants were the target.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Clinical T2b-T2c or lower disease. Gleason Grade group 2 or 3 on biopsy. PSA ≤20 ng/mL. Adult men \>30 and \< 75 years old. Currently diagnosed with Diabetes Mellitus and meet one of the following criteria for overweight or obesity:.
The full record lists 15 inclusion and 21 exclusion criteria; among the exclusions: pt3a or higher disease; grade group 4 or 5 adenocarcinoma of prostate; presence of metastatic disease on imaging.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2025-07-02 with completion listed for 2026-12-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year).
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Tirzepatide in 30 people.
Its size is small, so on its own it can only give an early look.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.