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

未提供0 个研究点目标入组 270 人开始时间: 待定

适应症

试验速览

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•Legal age of consent and at least 18 years old
•_BMI is greater than or equal to 30 kg/m2 or
•_BMI is greater than or equal to 25 kg/m2 and less than 30 kg/m2 with at least one of the following weight-related comorbidities:
•_Hypertension
•_Prediabetes
•_Dyslipidemia
•_Cardiovascular disease
•_Obstructive sleep apnea
•Study 2 -BMI is greater than or equal to 25 kg/m2 and T2DM defined as below:
•_Established diagnosis of T2DM
•_Without established diagnosis of T2DM and HbAlc is greater than or equal to 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 l -Established diagnosis of T1DM or T2DM.
•Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
•_HbAlc is greater than or equal to 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

发起方

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