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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well elecoglipron works for weight loss and how safe it is, along with diet and exercise. It compares the drug with a placebo, which has no active drug. There are two studies for adults with obesity or overweight: one without type 2 diabetes and one with type 2 diabetes.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and old enough to legally agree to join.
  • Study 1: Have a BMI of 30 or higher, or a BMI from 25 to under 30 with a listed weight-related health problem. BMI is a measure based on height and weight.
  • Study 1: Listed health problems are high blood pressure, prediabetes, unhealthy blood fat levels, heart or blood vessel disease, or sleep apnea (breathing that stops and starts during sleep).
  • Study 2: Have a BMI of 25 or higher and type 2 diabetes.
  • Study 2: Type 2 diabetes can be already diagnosed or shown by an HbA1c of 6.5% or higher at screening. HbA1c measures average blood sugar.
  • Your weight must not have changed by more than 5% in the 90 days before screening.
  • Have tried at least once to lose weight through diet without success.

Who can't join

  • Study 1: Have a diagnosis of type 1 or type 2 diabetes.
  • Study 2: Have type 1 diabetes or an HbA1c of 10% or higher at screening.
  • Study 2: Are getting, or are expected to need, treatment for diabetes-related eye damage or swelling.
  • Study 2: Had more than one severe low blood sugar episode in the 180 days before screening, or have trouble noticing low blood sugar.
  • Have had pancreatitis (swelling of the pancreas), either sudden or long-lasting. An exception may apply if it was caused by gallstones, has resolved, and your gallbladder was removed.
  • You or a biological parent, sibling, or child have had medullary thyroid cancer or multiple endocrine neoplasia type 2 (a condition that causes tumors in hormone-making glands).

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (56)

AL

AR

AZ

CA

CO

CT

FL

GA

ID

IL

IN

KS

KY

LA

MD

MI

MO

MS

NC

NM

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

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UT

VA

WV