Clinical Trials List
Protocol NumberD8750C00012
NCT Number(ClinicalTrials.gov Identfier)NCT07784270
Not yet recruiting
2026-08-01 - 2028-12-31
Phase III
Not yet recruiting1
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)
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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
Co-Principal Investigator
- 嚴愛文 Division of General Internal Medicine
- 林家宏 Division of General Internal Medicine
- 賴瑩純 Division of General Internal Medicine
- Tieng-Chun Chang Division of General Internal Medicine
- 粘峯榕 Division of General Internal Medicine
Co-Principal Investigator
- 吳韋璁 Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Mei Yueh Lee Division of Cardiovascular Diseases
Co-Principal Investigator
- 陳宗伯 Division of Family Medicine
- Hua-Shui Hsu Division of Family Medicine
Principal Investigator
Horng-Yih Ou
Co-Principal Investigator
- 林景翰 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Obesity or Overweight
Objectives
本試驗旨在評估 AZD6234 相較於安慰劑（每週一次皮下注射 [SC]），用於 ≥ 18 歲、患有 T2DM 且肥胖或過重的參與者進行體重管理的療效、安全性與耐受性。
Test Drug
注射液
Active Ingredient
AZD6234
Dosage Form
279
Dosage
1.5 mg/0.6 mL/Vial、4.5 mg/0.6 mL/Vial、9 mg/0.6 mL/Vial、18 mg/0.6 mL/Vial
Endpoints
•評估在治療 68 週時，AZD6234 相較於安慰劑對體重自基準期以來百分比變化的效果
Inclution Criteria
Inclusion Criteria:
Males & females (inclusive of all gender identities) age ≥18 years
BMI ≥27 kg/m2
Diagnosed with T2DM ≥90 days prior to Screening
HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
History of at least one self-reported unsuccessful attempt to lose body weight in lifetime
Males & females (inclusive of all gender identities) age ≥18 years
BMI ≥27 kg/m2
Diagnosed with T2DM ≥90 days prior to Screening
HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
History of at least one self-reported unsuccessful attempt to lose body weight in lifetime
Exclusion Criteria
Exclusion Criteria:
Obesity primarily caused by other endocrine disorders
Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 X ULN
AST ≥ 3.0 X ULN
TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
Use of insulin therapy for T2DM within 3 months prior to screening
Obesity primarily caused by other endocrine disorders
Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 X ULN
AST ≥ 3.0 X ULN
TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
Use of insulin therapy for T2DM within 3 months prior to screening
The Estimated Number of Participants
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Taiwan
167 participants
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Global
1500 participants
