Clinical Trials List
Protocol NumberWC45726
NCT Number(ClinicalTrials.gov Identfier)NCT07351058
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 and 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
Co-Principal Investigator
- 柯富翔 Division of Endocrinology
- 吳崇暉 Division of Endocrinology
- 蘇冠伃 Division of Endocrinology
- Chin-Sung Kuo Division of Endocrinology
Principal Investigator
周莒光
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 、Type 2 Diabetes Mellitus
Objectives
本試驗的目的是要針對罹患第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)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:
Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
Body mass index (BMI) ≥27.0 kg/m^2
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)
Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
Body mass index (BMI) ≥27.0 kg/m^2
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion Criteria
Exclusion Criteria:
History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
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)
Poorly controlled hypertension at screening
Have 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
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 any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
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)
Poorly controlled hypertension at screening
Have 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
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
1600 participants
