Endometrial CancerEarly Phase 1NCT06751589
A Study of a Weight Loss Intervention in People With Endometrial Cancer
A Early Phase 1 study testing Tirzepatide in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Dec 2024to Dec 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- Creatinine clearance (per Cockcroft-Gault formula) ≥30 mL/min Creatinine clearance (mL/min) = ((140-age)*wt) * 0.85 for female/(creatinine*72)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN.
- Total serum bilirubin ≤ 1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Pilot Weight Loss Intervention With Dual GIP/GLP-1 Receptor Agonist Therapy in Patients With Endometrial Cancer and Obesity, Overweight, With or Without Diabetes
The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.
- Conditions
- Endometrial Cancer
- Being tested
- Tirzepatide
- Keywords
- tirzepatide, semaglutide, dual GIP/GLP-1 receptor, obesity, overweight, diabetes, stage I-III endometrial cancer
- Medical subject headings
- Endometrial Neoplasms, Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly.
| Study group | Role | What they receive |
|---|---|---|
| tirzepatide | Experimental | Patients will meet with the study endocrinologist during screening and be prescribed SC tirzepatide 2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly. If insurance does not cover tirzepatide, the GLP-1 agonist semaglutide (Wegovy, Ozempic) initiated at 0.25 mg weekly SC may be substituted if deemed appropriate by the study PI. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients that complete treatment
measured by the percentage of patients that complete at least 70% of weekly doses, specifically 17 out of 24 weekly doses.
Measured: 1 year
Secondary outcomes (1)
frequency of gastrointestinal adverse events
as graded by CTCAE 5.0 that are attributable to the study treatment (tirzepatide) and occur during the on-treatment period from baseline initiation of the intervention to the end of study
Measured: up to 24 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start19 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Model description
- This is a single institution, single arm pilot study among Endometrial Cancer (EC) patients with obesity/overweight or diabetes undergoing chemotherapy to determine the feasibility and and preliminary efficacy of a weight loss intervention with weekly SC tirzepatide.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sminu Bose, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751589
- Sponsor's protocol ID
- 24-331
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Weight Loss Intervention With Dual GIP/GLP-1 Receptor Agonist Therapy in Patients With Endometrial Cancer and Obesity, Overweight, With or Without Diabetes
- ClinicalTrials.gov ID
- NCT06751589
- Acronym / sponsor ID
- 24-331
- Conditions
- Endometrial Cancer
- Keywords
- tirzepatide, semaglutide, dual GIP/GLP-1 receptor, obesity, overweight, diabetes, stage I-III endometrial cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2024 (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 researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single institution, single arm pilot study among Endometrial Cancer (EC) patients with obesity/overweight or diabetes undergoing chemotherapy to determine the feasibility and and preliminary efficacy of a weight loss intervention with weekly SC tirzepatide.
| Arm | Type | Receives |
|---|---|---|
| tirzepatide | Experimental | Drug: TirzepatidePatients will meet with the study endocrinologist during screening and be prescribed SC tirzepatide 2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly. If insurance does not cover tirzepatide, the GLP-1 agonist semaglutide (Wegovy, Ozempic) initiated at 0.25 mg weekly SC may be substituted if deemed appropriate by the study PI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Tirzepatide2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly. | Drug | tirzepatide |
Primary outcome
percentage of patients that complete treatment
Time frame: 1 year
measured by the percentage of patients that complete at least 70% of weekly doses, specifically 17 out of 24 weekly doses.
1 secondary outcome
frequency of gastrointestinal adverse events
Time frame: up to 24 2weeks
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 21 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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. This study is not recruiting at the moment.
Sminu Bose, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites 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 Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 16 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients that complete treatment (time frame: 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 21 Oct 2026.