Recruiting NCT07667803

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

Phase III Interventional Weight Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Elecoglipron, Placebo.
Who it may be relevant to: Registry conditions: Weight Management. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

Overview

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).

Detailed description

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.

Interventions

Drug Elecoglipron
Elecoglipron film-coated tablet once daily
Drug Placebo
Placebo matching elecoglipron film-coated tablet once daily

Primary outcome measures

Percent body weight loss [Time frame: 72 weeks]

Secondary outcome measures (8)

Absolute body weight loss [Time frame: 72 weeks]
Total body weight loss of at least 5%, 10%, and 15% [Time frame: 72 weeks]
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline [Time frame: 72 weeks]
Waist circumference reduction [Time frame: 72 weeks]
Glycemic control [Time frame: 72 weeks]
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline [Time frame: 72 weeks]
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline [Time frame: 72 weeks]
Systolic blood pressure reduction [Time frame: 72 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment