Clinical Trials List
2026-07-01 - 2029-12-30
Phase III
Not yet recruiting10
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)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/08
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 吳韋璁 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 陳文昭 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Hua-Shui Hsu Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
•自基準期到第 72 週的體重百分比變化
Inclution 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
The Estimated Number of Participants
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Taiwan
200 participants
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Global
4500 participants
