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

4500 patients around the world

Available in United States, Chile, Brazil, Argentina

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

AstraZeneca

4500Patients around the world

This study is for people with

Obesity

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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.

StudyEmbold

SponsorAstraZeneca

Study typeInterventional

Conditions

Obesity

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07667803