Elecoglipron for Weight Management in Overweight Adults
A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
Recruiting
Phase 3Interventional Study
Weight Management
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
4,500 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight. Participants will take a medication called elecoglipron while following a diet and exercise program to help manage their weight.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPancreatitisMedullary thyroid cancer
You may be able to join if
I am at least 18 years old
I have a BMI of 30 or more, or a BMI between 25 and 30 with a weight-related health issue
I have a history of trying to lose weight unsuccessfully
I have had a stable body weight for the last 90 days
You may not be able to join if
I have been diagnosed with Type 1 or Type 2 diabetes
I have had severe low blood sugar episodes recently
I have a history of pancreatitis
I have a family history of medullary thyroid cancer
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-relat…
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).
Trial Locations
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Eligibility Criteria
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 a…
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 neoplasia type 2
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