Clinical Trials List
Protocol NumberWC45725
NCT Number(ClinicalTrials.gov Identfier)NCT07351045
Active
2026-03-01 - 2030-12-31
Phase III
Not yet recruiting1
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes
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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
2026/09/10
Investigators and Locations
Principal Investigator
周莒光
Co-Principal Investigator
- 吳崇暉 Division of Endocrinology
- 蘇冠伃 Division of Endocrinology
- Chin-Sung Kuo Division of Endocrinology
- 柯富翔 Division of Endocrinology
Co-Principal Investigator
- Hua-Shui Hsu Division of Family Medicine
Principal Investigator
Yi-Ching Yang
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Obesity or Overweight
Objectives
本試驗的目的是要針對無罹患第2型糖尿病(T2DM)、肥胖(體重指數[BMI]>=30 kg/m^2)或過重(BMI>=27且< 30 kg/m^2)並有至少一項體重相關共病的參與者，評估RO7795068 (一種胰高血糖素樣肽-1 [GLP-1]/葡萄糖依賴性促胰島素多肽[GIP]雙受體作用劑[RA])作為低熱量飲食及增加體能活動之輔助手段的療效與安全性。
(詳細內容請參照本試驗計畫書及計畫中文摘要)
Test Drug
注射劑
Active Ingredient
RO7795068
Dosage Form
270
Dosage
4 mg/0.4 ml； 8 mg/0.8 ml； 12 mg/0.4 ml； 16mg/0.53 ml； 20 mg/0.67 ml； 24 mg/0.8 ml
Endpoints
● 評估RO7795068相較於安慰劑對體重管理的影響
- 第72週時，體重相較於基準期的百分比(%)變化
(完整資訊請參照計畫書)
- 第72週時，體重相較於基準期的百分比(%)變化
(完整資訊請參照計畫書)
Inclution Criteria
Inclusion Criteria:
Participants must have at screening:
Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Participants must have at screening:
Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Exclusion Criteria
Exclusion Criteria:
History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
Self-reported change in body weight >5 kg within 3 months prior to screening
Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
Poorly controlled hypertension at screening
Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
Self-reported change in body weight >5 kg within 3 months prior to screening
Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
Poorly controlled hypertension at screening
Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
The Estimated Number of Participants
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Taiwan
240 participants
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Global
2000 participants
