Clinical Trials List
Protocol NumberD8750C00014
NCT Number(ClinicalTrials.gov Identfier)NCT07784725
Not yet recruiting
2026-08-01 - 2029-12-31
Phase III
Not yet recruiting1
A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)
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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
- 陳怡文 Division of Endocrinology
- Chih-Yiu Tsai Division of Endocrinology
- 王涵芸 Division of Endocrinology
- 林怡瑄 Division of Endocrinology
- 林承緯 Division of Endocrinology
Co-Principal Investigator
- 朱志生 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
Co-Principal Investigator
- 賴瑩純 Division of Endocrinology
- 嚴愛文 Division of Endocrinology
- 粘峯榕 Division of Endocrinology
- 林家宏 Division of Endocrinology
- Tieng-Chun Chang Division of Endocrinology
Principal Investigator
周莒光
Principal Investigator
Yi-Ching Yang
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（每週給藥一次，皮下注射 [SC]）用於年齡 ≥ 18 歲肥胖或過重且患有相關共病症受試者之體重管理的療效、安全性和耐受性。
Test Drug
皮下注射劑
Active Ingredient
AZD6234
Dosage Form
220
Dosage
1.5 mg/0.6 mL、4.5 mg/0.6 mL、9 mg/0.6 mL、18 mg/0.6 mL
Endpoints
•治療 68 週後體重相較於基準期的變化百分比
Inclution Criteria
Inclusion Criteria:
Males & females (inclusive of all gender identities) age ≥18 years
BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
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 their lifetime
Males & females (inclusive of all gender identities) age ≥18 years
BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
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 their lifetime
Exclusion Criteria
Exclusion Criteria:
Obesity primarily caused by other endocrine disorders
History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 × ULN
AST ≥ 3.0 × ULN
TBL > 1.5 × 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.
Obesity primarily caused by other endocrine disorders
History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 × ULN
AST ≥ 3.0 × ULN
TBL > 1.5 × 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.
The Estimated Number of Participants
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Taiwan
160 participants
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Global
2500 participants
