DiabetesEarly Phase 1NCT06759701
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
A Early Phase 1 study testing Tirzepatide in people with Diabetes and Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes, Prostate Cancer
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Justin Gregg, MD, 713-792-3250, jrgregg@mdanderson.org
Justin Gregg, MD
About this study
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer
Read the detailed description
Primary Objectives:
To determine the feasibility of a tirzepatide-assisted weight loss program prior to radical prostatectomy in a group of men diagnosed with intermediate risk prostate cancer, defined based on the following process measures:
Enrollment (completion of 30 patient accrual within 2 years) Retention (completion of the study through the day of surgery, with ≥90% defined as successful) Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).
Secondary Objectives:
- Determine differences in plasma and tumor sphingolipids following tirzepatide-based intervention
- Determine differences in markers of insulin and insulin signaling following tirzepatide-based intervention
- Determine differences in prostate, plasma and periprostatic fat inflammatory signaling following tirzepatide-based intervention
- Determine differences in tumor proliferation following tirzepatide-based intervention, including when stratified by obesity- and prostate cancer-associated SNPs and GLP-1 expression.
- Determine differences in ASCVD risk factors following tirzepatide-based intervention.
- Determine differences in other markers of cardiovascular risk.
- Determine changes in body scan as measured by DEXA scan after tirzepatide-based intervention
- Determine change in body weight following tirzepatide-based intervention.
- Determine changes in gut microbiome alpha and beta diversity following tirzepatide-based intervention.
- Determine rates of biochemical recurrence, receipt of salvage radiation therapy, and receipt of androgen deprivation therapy, stratified by prostatectomy pathology, after tirzepatidebased intervention
Correlative Outcomes Cardiovascular, Surgical, and Patient-Related Outcomes Outcome Measure Outcome Measure Difference in plasma sphingolipids Change in plasma sphingolipid signature from baseline to pre-surgery within patients Difference in ASCVD risk factor score Change in the Metabolic Syndrome Severity Score (MetSSS)32
Difference in insulin signaling Compare change in fasting insulin, IGFBP-3, IGF-1 and C-peptide within patients Difference other markers of cardiovascular disease risk Between-group difference hsCRP, YKL-40, ICAM-1, E-selectin, leptin, and lipoproteins (e.g. LDL, LP(a)) Difference in tumor and periprostatic fat inflammatory markers Tumor and peri-prostatic fat inflammatory mRNA levels (CXCL12, CXCL1, CCR7 and IL-6, TNF-α) Change is DEXA-defined body composition measures Change in body fat percent, appendicular lean mass index, and other indices Compare tumor ki67 and other relevant proteins stratified by tumor GLP-1 receptor expression and Decipher score Spearman correlation of tumor ki67 change with GLP-1 receptor density (based on IHC). Analyses stratified by Decipher and other groups, as well. Change in body weight Change in the absolute body weight
Determine differences in tumor proliferation stratified by germline obesity- and prostate cancer-associated germline SNPs Stratified analysis of ki67 expression based on germline genotype at rs12529, rs6161, rs523349, and rs1047303.
Determine changes in the gut microbiome with use of GLP-1 assisted weigh loss Established measures of alpha and beta diversity of microbial species
- Conditions
- Diabetes, Prostate Cancer
- Being tested
- Tirzepatide
- Medical subject headings
- Diabetes Mellitus, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Participants will perform weekly self-injection of tirzepatide as standard of care, following manufacturer instructions
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Not described Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start2 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Gregg, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759701
- Sponsor's protocol ID
- 2024-1496
- Other IDs
- NCI-2024-10696
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06759701
- Acronym / sponsor ID
- 2024-1496
- Conditions
- Diabetes, Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer
Detailed description
Primary Objectives:
To determine the feasibility of a tirzepatide-assisted weight loss program prior to radical prostatectomy in a group of men diagnosed with intermediate risk prostate cancer, defined based on the following process measures:
Enrollment (completion of 30 patient accrual within 2 years) Retention (completion of the study through the day of surgery, with ≥90% defined as successful) Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).
Secondary Objectives:
- Determine differences in plasma and tumor sphingolipids following tirzepatide-based intervention
- Determine differences in markers of insulin and insulin signaling following tirzepatide-based intervention
- Determine differences in prostate, plasma and periprostatic fat inflammatory signaling following tirzepatide-based intervention
- Determine differences in tumor proliferation following tirzepatide-based intervention, including when stratified by obesity- and prostate cancer-associated SNPs and GLP-1 expression.
- Determine differences in ASCVD risk factors following tirzepatide-based intervention.
- Determine differences in other markers of cardiovascular risk.
- Determine changes in body scan as measured by DEXA scan after tirzepatide-based intervention
- Determine change in body weight following tirzepatide-based intervention.
- Determine changes in gut microbiome alpha and beta diversity following tirzepatide-based intervention.
- Determine rates of biochemical recurrence, receipt of salvage radiation therapy, and receipt of androgen deprivation therapy, stratified by prostatectomy pathology, after tirzepatidebased intervention
Correlative Outcomes Cardiovascular, Surgical, and Patient-Related Outcomes Outcome Measure Outcome Measure Difference in plasma sphingolipids Change in plasma sphingolipid signature from baseline to pre-surgery within patients Difference in ASCVD risk factor score Change in the Metabolic Syndrome Severity Score (MetSSS)32
Difference in insulin signaling Compare change in fasting insulin, IGFBP-3, IGF-1 and C-peptide within patients Difference other markers of cardiovascular disease risk Between-group difference hsCRP, YKL-40, ICAM-1, E-selectin, leptin, and lipoproteins (e.g. LDL, LP(a)) Difference in tumor and periprostatic fat inflammatory markers Tumor and peri-prostatic fat inflammatory mRNA levels (CXCL12, CXCL1, CCR7 and IL-6, TNF-α) Change is DEXA-defined body composition measures Change in body fat percent, appendicular lean mass index, and other indices Compare tumor ki67 and other relevant proteins stratified by tumor GLP-1 receptor expression and Decipher score Spearman correlation of tumor ki67 change with GLP-1 receptor density (based on IHC). Analyses stratified by Decipher and other groups, as well. Change in body weight Change in the absolute body weight
Determine differences in tumor proliferation stratified by germline obesity- and prostate cancer-associated germline SNPs Stratified analysis of ki67 expression based on germline genotype at rs12529, rs6161, rs523349, and rs1047303.
Determine changes in the gut microbiome with use of GLP-1 assisted weigh loss Established measures of alpha and beta diversity of microbial species
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: Tirzepatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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):
- Adult men >30 and < 75 years old
- Currently diagnosed with Diabetes Mellitus and meet one of the following criteria for overweight or obesity:
- 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:
Key exclusion criteria (21 listed)
- Prostate cancer that meets factors as part of NCCN high and very high-risk criteria (as follows):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideParticipants will perform weekly self-injection of tirzepatide as standard of care, following manufacturer instructions | Drug | Tirzepatide |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Gregg, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tirzepatide in people with Diabetes and Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Gregg, MD ((713) 792-3250, jrgregg@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.