A master protocol to investigate efficacy and safety of elecoglipron in participants with obesity or overweight with or without T2DM - Embold

Inclusion 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