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

Prior treatment

• History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis

Other illness

• History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2

Lab values

• 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

Other

• Study 1 - Established diagnosis of T1DM or T2DM.

• 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.