NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

NCT07667803

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Weight Management

Interventions: Elecoglipron, Placebo

Countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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

Locations (321)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Chandler, Arizona, United States
Peoria, Arizona, United States
Little Rock, Arkansas, United States
Lynwood, California, United States
Rolling Hills Estates, California, United States
Sacramento, California, United States
Arvada, Colorado, United States
New Haven, Connecticut, United States
Clearwater, Florida, United States
Plantation, Florida, United States
Woodstock, Georgia, United States
Ammon, Idaho, United States
Melrose Park, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Alexandria, Louisiana, United States
Baltimore, Maryland, United States
Potomac, Maryland, United States
White Marsh, Maryland, United States
Ypsilanti, Michigan, United States
Ridgeland, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Laurelton, New York, United States
+ 291 more on CT.gov