A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity… (NCT07667803) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
United States, Argentina, Australia4,500 participantsStarted 2026-07-06
Plain-language summary
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Legal age of consent and at least 18 years old
* Study 1 -
* BMI ≥ 30 kg/m2 or
* 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities:
* Hypertension
* Prediabetes
* Dyslipidemia
* Cardiovascular disease
* Obstructive sleep apnea.
* Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:
* Established diagnosis of T2DM
* Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
* Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria
* Study 1 - Established diagnosis of T1DM or T2DM.
* Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
* T1DM
* HbA1c ≥ 10% (86 mmol/mol) at the screening visit
* Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
* Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
* History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
* History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neopla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.