DelfaGLP-1 Atlas

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RecruitingPhase EARLY_1

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

Pilot Weight Loss Intervention With Dual GIP/GLP-1 Receptor Agonist Therapy in Patients With Endometrial Cancer and Obesity, Overweight, With or Without Diabetes

Assets

Semaglutide / Tirzepatide

Listed sites

7

Recruiting sites

7

Enrollment

36

estimated

Study population

Obesity / overweight, Oncology

Key I/E criteria

•BMI ≥30•HbA1c ≥6.5%•Female

Primary endpoint

•Percentage of patients that complete treatment

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 IDNCT06751589
Org study ID24-331

Timeline

Milestones

Study start2024-12-19actual
Study first posted2024-12-30actual
Last update posted2026-04-13actual
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

SemaglutideTirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•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:

1. Creatinine clearance (per Cockcroft-Gault formula) ≥30 mL/min Creatinine clearance (mL/min) = ((140-age)*wt) * 0.85 for female/(creatinine*72)

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN.

3. 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).

Exclusion criteria

•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.

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint/low confidence

percentage of patients that complete treatment

Time frame:1 year

threshold achievement, descriptive

Secondary/protocol endpoint

frequency of gastrointestinal adverse events

Time frame:up to 24 2weeks

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.