Weight Loss Intervention for Endometrial Cancer with Tirzepatide

This study is looking at whether tirzepatide can help people with endometrial cancer manage their weight and blood sugar while undergoing chemotherapy. Researchers will also observe your experience with the medication, its safety when taken with chemotherapy, and changes in your weight, body fat, and blood pressure. You may be able to join if you are an adult woman with endometrial cancer, are at least 18 years old, and have obesity (BMI of 30 or higher) or are overweight (BMI of 27 or higher) with other weight-related health issues, or have Type 2 Diabetes with a BMI of 25 or higher. The main goal is to see what percentage of patients complete the treatment over one year. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 36 participants. It is not specified if it is randomized or blinded.
What's involved
You would take tirzepatide once weekly, starting at 2.5 mg for 4 weeks and then increasing to 5 mg once weekly. The study will measure your progress for one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to measure the percentage who complete treatment.

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NCT06751589

A Study of a Weight Loss Intervention in People With Endometrial Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~36 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
percentage of patients that complete treatment
Measured over 1 year
Endometrial Cancer
7 sites across 2 states
New York4
New Jersey3
  • Sminu Bose, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Obesity (defined as BMI ≥ 30 kg/m2) OR Overweight (defined as BMI ≥ 27 kg/m2) with presence of ≥1 weight related comorbid condition OR a diagnosis of Type 2 Diabetes Mellitus with BMI ≥ 25 kg/m2
Type 2 Diabetes Mellitus is defined as known history of Type 2 diabetes, HbA1c ≥ 6.5%, fasting blood glucose ≥126 mg/dL on 2 occasions, or random blood glucose ≥ 200 mg/dL with signs and symptoms of diabetes mellitus (weight loss, fatigue, polyuria, polydipsia, vision changes)
Patients with new diagnosis of stage I-III endometrial cancer
Completed surgery with TH/BSO with no gross residual disease
Recommended to undergo curative intent adjuvant chemotherapy at MSK with or without intravaginal radiation or external pelvic radiation. Chemotherapy regimen must include carboplatin and paclitaxel x 4-6 cycles. Cisplatin may be included at the discretion of the treating physician during concurrent standard chemoradiation. Patients may consent prior to and up to 8 weeks after the first cycle of chemotherapy.
Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, carcinosarcoma, undifferentiated carcinoma/de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), and mucinous adenocarcinoma.
Patient has adequate organ function, as defined by the following laboratory values:
Insurance approval for tirzepatide or semaglutide (alternative) or willingness to pay out-of-pocket for tirzepatide or semaglutide (alternative) for duration of study period
Patients must be capable and willing to learn how to self-inject study drug, as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug) and administer study drug injection (or receive an injection from a trained individual if visually impaired or with physical limitations)
Not pregnant and not nursing
English speaking or a family member or caregiver who speaks English and is able to assist with smart phone or tablet based Keenoa app or paper dietary recall handout (if no access to smart phone or tablet).

Exclusion

Known Type 1 diabetes
Known GAD, Islet Cell, or Zn Transporter 8 antibodies
History of gastroparesis
High risk for aspiration
Active or history of chronic or acute pancreatitis
History of elevated calcitonin
Personal or family history of Medullary Thyroid Carcinoma with Multiple Endocrine Neoplasia-2 syndrome
Patients with a prior surgical, endoscopic, and/or device-based therapy (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenojejunal bypass sleeve) for obesity within the past two years
Patients with removal of device-based therapy for obesity within the last 6 months
Current GIP/GLP-1 or GLP-1 receptor agonist use or prior intolerance of GIP/GLP-1 or GLP-1 receptor agonist
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Known intolerance to study drug(s) or any of the excipients.
  • percentage of patients that complete treatment1 year

    measured by the percentage of patients that complete at least 70% of weekly doses, specifically 17 out of 24 weekly doses.