PACTR202607874630774进行中（未招募）3 期
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)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1 Participant must be of the legal age of consent and at least 18 years of age at the time of signing informed consent.
- •Type of Participant and Disease Characteristics
- •2 At the screening visit:
- •(a) BMI = 30 kg/m2 or
- •(b) 25 kg/m2 = BMI < 30 kg/m2 (participants with 25 kg/m2 = BMI < 27 kg/m2 must also have a waist-to-height ratio = 0.5) with at least one of the following weight-related comorbidities (treated or untreated):
- •(i) Hypertension
- •(ii) Prediabetes (Note: For this study, the diagnosis of prediabetes should be supported by a historical laboratory value not older than 180 days, fitting the definition of prediabetes according to ADA guidelines [ADA Professional Practice Committee 2025a])
- •(iii) Dyslipidemia
- •(iv) Cardiovascular disease
- •(v) Obstructive sleep apnea.
- •2 At the screening visit, BMI = 25 kg/m2 (participants with 25 kg/m2 = BMI < 27 kg/m2 must also have a waist-to-height ratio = 0.5) and T2DM defined as below:
- •(a) Established diagnosis of T2DM as per ADA or local diagnostic standards. T2DM may be treated with diet/exercise alone or any glucose-lowering medications except GLP-1 RA containing medications within 90 days prior to the screening visit or during the screening period.
- •(b) Without established diagnosis of T2DM and HbA1c = 6.5% (48 mmol/mol) at the screening visit confirmed by post screening retesting prior to randomization. Participants with T2DM detected at screening and a HbA1c = 8.5% (69 mmol/mol) or overt signs/symptoms of hyperglycemia must be rescreened after a 90-day period, during which they should receive standard of care glucose management except GLP-1 RA containing medications. Participants with HbA1c < 8.5% (69 mmol/mol) may proceed with randomization, provided all other eligibility criteria are met.
- •Note: Participant’s assignment to Study 1 or Study 2 based on T2DM-related inclusion criteria is depicted in Figure
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1 Any of the following medical history or laboratory values:
- •(a) Established diagnosis of T1DM or T2DM. History of gestational diabetes is not an exclusion criterion per se.
- •(b) HbA1c = 6.5% (48 mmol/mol) at the screening visit (one repeat test allowed).
- •1 Any of the following medical history, laboratory values, or complications related to diabetes:
- •(a) T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma within 180 days prior to the screening visit or during the screening period.
- •(b) HbA1c = 10% (86 mmol/mol) at the screening visit (one repeat test allowed).
- •(c) Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema. Fundus photography or dilated fundoscopic exam will be performed as per the SoA (Section 1.3) by an ophthalmologist/optometrist or according to local practice to confirm eligibility.
- •(d) Have had more than one episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 180 days prior to the screening visit or during the screening period, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as per Investigator judgment.
- •2 Any of the following that are related to medical reasons or planned/previous changes in weight (see further details in Section 5.3.5 and Appendix I):
- •(a) Obesity induced by other endocrine disorders such as Cushing’s syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
- •(b) Received any medication for weight loss, including GLP-1 RAs, within 90 days prior to the screening visit or during the screening period.
- •(c) Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
- •(d) Planned to start a targeted weight loss program during the study other than dietary and lifestyle considerations outlined in the protocol.
- •(e) Initiated therapy with, or altered the dosage of, medications associated with significant weight gain within 365 days prior to the screening visit or during the screening period (see Section 6.9.2.1 for details).
- •Gastrointestinal/Liver
- •3 Known clinically significant condition affecting the upper GI tract that may affect gastric emptying, drug absorption, or the interpretation of safety and tolerability data (eg, gastroparesis or gastric outlet obstruction, severe disease, or surgery).
- •4 Participants with history of any of the below conditions:
- •(a) Cirrhosis or hepatic decompensation (including ascites, hepatic encephalopathy, or variceal bleeding)
- •(b) Liver transplant or current placement on a liver transplant list
- •(c) Clinically significant liver disease of any etiology as judged by the Investigator, including but not limited to alcoholic steatohepatitis, drug-induced, viral, or autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, alpha-1 antitrypsin deficiency, and Wilson’s disease
- •Exceptions include: participants with metabolic dysfunction-associated steatotic liver disease or metabolic dysfunction associated steatohepatitis.
- •5 Any of the following results at the screening visit:
- •(a) ALT = 3 × ULN
- •(b) AST = 3 × ULN
- •(c) ALP = 1.5 × ULN
- •(d) TBIL = 1.5 × ULN
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