← Trials/Trial dossier/NCT06759701
RecruitingPhase EARLY_1
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
30
estimated
Study population
Obesity / overweight, Oncology
Key I/E criteria
•BMI ≥27•Male
Primary endpoint
•Treatment-emergent AEs (any)
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 IDNCT06759701
Org study ID2024-1496
Secondary IDNCI-2024-10696NCI-CTRP Clinical Trials Registry
Timeline
Milestones
Study first posted2025-01-06actual
Study start2025-07-02actual
Last update posted2026-02-27actual
Primary completion2026-12-31estimated
Study completion2028-12-31estimated
Assets
Investigational agents
Study populations
Who this study enrolls
Obesity / overweightOncology
Eligibility
Who can enroll
Minimum age18 Years
SexMale
Healthy volunteersNot accepted
Inclusion criteria
•Histologically confirmed adenocarcinoma of the prostate that is localized (no metastatic lesions or concerning lymph nodes 1cm or greater) based on prostate MRI and meets NCCN intermediate risk criteria (as follows):
–Clinical T2b-T2c or lower disease
–Gleason Grade group 2 or 3 on biopsy
–PSA ≤20 ng/mL
–Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist
•Adult men >30 and < 75 years old
•Currently diagnosed with Diabetes Mellitus and meet one of the following criteria for overweight or obesity:
–Body Mass Index (BMI) greater than or equal to 27 kg/m2
–Waist circumference (> 40 inches) -or-
•Currently have a BMI greater or equal to 30 kg/m2 -or-
•Currently have a BMI greater or equal to 27 kg/m2 with at least one weight-related condition, defined as one or more of the following:
–Hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg or diastolic blood pressure ≥80 mmHg
–Dyslipidemia: treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40mg/dL (1.0 mmol/L)
–Obstructive sleep apnea
–Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
Exclusion criteria
•Prostate cancer that meets factors as part of NCCN high and very high-risk criteria (as follows):
–pT3a or higher disease
–Grade group 4 or 5 adenocarcinoma of prostate
•Presence of metastatic disease on imaging
•A history of intentional or unintentional weight loss of more than 5kg within 90 days of screening
•Any prior androgen deprivation, chemotherapy, surgery, or radiation for PCa
•Previous or planned surgical treatment for obesity or use of a medication that promotes weight loss within 90 days before screening
•Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 as determine using standard MD Anderson laboratory measures
•Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility
•Have had a history of chronic or acute pancreatitis
•Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years
–Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications
•Have any of the following cardiovascular conditions within 3 months prior to study enrollment: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
•Have NYHA Functional Classification IV CHF
•Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of the following, as determined by the central laboratory during screening: - alanine aminotransferase (ALT) level >3.0X the upper limit of normal (ULN) for the reference range or - alkaline phosphatase (ALP) level >1.5X the ULN for the reference range or - total bilirubin level >1.2X the ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: Participants with nonalcoholic fatty liver disease are eligible to participate in this trial if their ALT level is ≤3.0X the ULN for the reference range
•Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2
•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix), other than prostate cancer, for less than 5 years
•Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1R agonists
•Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
•Have history of use of marijuana within 3 months of enrollment and unwillingness to abstain from marijuana use during the trial. Participants should also refrain from use of cannabidiol oil for the duration of the study
•Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant.
Endpoints (1)
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.
Safety / tolerability / PK
1 endpointPrimary/protocol endpoint
Safety and Adverse Events (AEs)
Time frame:Through study completion; an average of 1 year
Treatment-emergent AEs (any)
event count, 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.