A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
Recruiting · NCT07667803 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
ElecoglipronPlacebo
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 34 US states.
- Research Site - Birmingham, Alabama, United States
- Research Site - Birmingham, Alabama, United States
- Research Site - Dothan, Alabama, United States
- Research Site - Dothan, Alabama, United States
- Research Site - Chandler, Arizona, United States
- Research Site - Chandler, Arizona, United States
- Research Site - Sun City, Arizona, United States
- Research Site - Sun City, Arizona, United States
- Research Site - Little Rock, Arkansas, United States
- Research Site - Little Rock, Arkansas, United States
- Research Site - Lynwood, California, United States
- Research Site - Lynwood, California, United States
- Research Site - Rolling Hills Estates, California, United States
- Research Site - Rolling Hills Estates, California, United States
- Research Site - Sacramento, California, United States
- Research Site - Sacramento, California, United States
- Research Site - Arvada, Colorado, United States
- Research Site - Arvada, Colorado, United States
- Research Site - New Haven, Connecticut, United States
- Research Site - New Haven, Connecticut, United States
- Research Site - Plantation, Florida, United States
- Research Site - Plantation, Florida, United States
- Research Site - Tampa, Florida, United States
- Research Site - Tampa, Florida, United States
- Research Site - Woodstock, Georgia, United States
- Research Site - Woodstock, Georgia, United States
- Research Site - Ammon, Idaho, United States
- Research Site - Ammon, Idaho, United States
- Research Site - Melrose Park, Illinois, United States
- Research Site - Melrose Park, Illinois, United States
- Research Site - Indianapolis, Indiana, United States
- Research Site - Indianapolis, Indiana, United States
- Research Site - Wichita, Kansas, United States
- Research Site - Wichita, Kansas, United States
- Research Site - Louisville, Kentucky, United States
- Research Site - Louisville, Kentucky, United States
- Research Site - Alexandria, Louisiana, United States
- Research Site - Alexandria, Louisiana, United States
- Research Site - Baltimore, Maryland, United States
- Research Site - Baltimore, Maryland, United States
- Research Site - Potomac, Maryland, United States
- Research Site - Potomac, Maryland, United States
- Research Site - White Marsh, Maryland, United States
- Research Site - White Marsh, Maryland, United States
- Research Site - Ypsilanti, Michigan, United States
- Research Site - Ypsilanti, Michigan, United States
- Research Site - Ridgeland, Mississippi, United States
- Research Site - Ridgeland, Mississippi, United States
- Research Site - Kansas City, Missouri, United States
- Research Site - Kansas City, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - Reno, Nevada, United States
- Research Site - Reno, Nevada, United States
- Research Site - Albuquerque, New Mexico, United States
- Research Site - Albuquerque, New Mexico, United States
- Research Site - Albany, New York, United States
- Research Site - Albany, New York, United States
- Research Site - Laurelton, New York, United States
- Research Site - Laurelton, New York, United States
Showing 60 of 650 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →