BridgeMD
A clinical trial studying the effect of Tirzepatide in women living with endometrial cancer
EU CTIS ID: 2025-523877-40-00
What this study is testing
The proportion (%) of patients with a pCR in each group 12 months (Visit 14, 52 weeks ±14 days) post randomization.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed FIGO grade 1 or 2 endometrioid adenocarcinoma on a curette or endometrial biopsy, p53 WT, MMR proficient.
- Serum CA125 ≤30 U/mL.
- No known hypersensitivity or contraindications for LNG-IUS (severe liver disease, personal history of breast cancer, active pelvic inflammatory disease, congenital uterine abnormality) or GLP-1 agonist
- Ability to comply with endometrial biopsies at specified 3 monthly intervals
- Inclusion of patients, who in the opinion of the gynaecological multidisciplinary team, at screening, are not suitable candidates for radiotherapy.
- Negative serum pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
You likely can't join if
- ECOG performance status ≥3
- Obesity induced by other endocrine disorders (e.g., Cushing syndrome)
- Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening visit, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), promtri-cyclic antidepressants, atypical antipsychotic and mood stabilisers (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- Grade 1 or 2 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 3 endometrioid adenocarcinoma
- Participation in a clinical trial of weight control within the last 3 months prior to screening for this trial
- Previous surgical treatment for obesity (excluding liposuction if performed >1 year before study entry)
See the full eligibility criteria
Who can join
- Histologically confirmed FIGO grade 1 or 2 endometrioid adenocarcinoma on a curette or endometrial biopsy, p53 WT, MMR proficient.
- Serum CA125 ≤30 U/mL.
- No known hypersensitivity or contraindications for LNG-IUS (severe liver disease, personal history of breast cancer, active pelvic inflammatory disease, congenital uterine abnormality) or GLP-1 agonist
- Ability to comply with endometrial biopsies at specified 3 monthly intervals
- Inclusion of patients, who in the opinion of the gynaecological multidisciplinary team, at screening, are not suitable candidates for radiotherapy.
- Negative serum pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- No LNG-IUS or LNG-IUS inserted < 6 weeks prior to enrolment
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
- Females with a BMI > 27 kg/m2 at high risk of surgical complications due to co-morbidities (diabetes, hypertension, cardiovascular disease, obstructive sleep apnoea) or BMI > 30 kg/m2 with no comorbidities and who are at risk of surgical complications or have decided not to opt for immediate surgical intervention (having been advised that this is the standard of care).
- Over 18 years of age at time of randomisation
- CT scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease in patients with endometrial cancer only
- Myometrial invasion on MRI of not more than 50%
- No lymph vascular invasion on biopsy.
What rules you out
- ECOG performance status ≥3
- Obesity induced by other endocrine disorders (e.g., Cushing syndrome)
- Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening visit, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), promtri-cyclic antidepressants, atypical antipsychotic and mood stabilisers (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- Grade 1 or 2 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 3 endometrioid adenocarcinoma
- Participation in a clinical trial of weight control within the last 3 months prior to screening for this trial
- Previous surgical treatment for obesity (excluding liposuction if performed >1 year before study entry)
- History of major depressive disorder or a PHQ-9 >15 within the last 2 years (completed at visit 1) or history of other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) or diagnosis of an eating disorder such as restrained eating, binge eating, or bulimia (based on Questionnaire for Diagnosing Binge Eating Disorder and Bulimia Nervosa completed at visit 1)
- Participants with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator
- Impaired liver function, defined as screening aspartate aminotransferase or alanine aminotransferase ≥ 2.5 times upper normal range (one re-test analyzed at the local laboratory within 1 week prior to screening is permitted with the last sample being conclusive)
- Impaired renal function defined as eGFR <90mL/min/1.73L2 (1 retest within 1 week prior to screening through the local laboratory is permitted with the result of the last sample conclusive)
- Evidence of extra-uterine extension on cross sectional imaging
- Known clinically significant active cardiovascular disease, including history of unstable angina, acute coronary event, other significant cardiac events (including history of arrhythmias, myocardial infarction (MI), or conduction delays on electrocardiogram [ECG]), or cerebral stroke within the past 6 months and/or heart failure (New York Heart Association [NYHA] Class III or IV) at the discretion of the Investigator
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥80 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at run-in prior to other trial-related activities is allowed
- Known or suspected abuse of alcohol or narcotics
- MMR deficient or p53 mutated endometrial cancer.
- Language barrier, mental incapacity, unwillingness or ability to understand and being able to complete the mental health questionnaire in the provided language
- History of breast, thyroid or colon cancer
- Current other cancer (past or present, except basal cell skin cancer or squamous cell skin cancer)
- Breastfeeding mothers
- Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
- Pregnant or planning to become pregnant during trial period
- Congenital or acquired uterine anomaly which distorts the uterine cavity
- Prior treatment for EAC
- Patients with a history of pelvic or abdominal radiotherapy
- Unwilling to have additional endometrial biopsies or unable to attend monthly clinical assessments
- Unable to provide informed consent or complete questionnaires
- Participants with a history of severe gastrointestinal disease, gastroparesis or significant dysmotility, or prior aspiration with anaesthesia
- Acute pelvic inflammatory disease and/or untreated sexually transmitted diseases and genital infections
- Genital actinomycosis
- History of pancreatitis
- Diagnosis of Type 1 diabetes
- Previous treatment with GLP-1 receptor agonists within the last 3 months
- Visit 1 thyroid-stimulatory hormone (TSH) outside of the range of 0.4-6.0 mIUl-1
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.