A Phase III, randomized, double -blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of once-weekly RO7795068 administered to Japanese patients with obesity

未提供0 个研究点目标入组 200 人开始时间: 待定

适应症

试验速览

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•Able and willing to self-administer the study drug. However, if you have visual impairment or physical limitations, you can receive the dose from a trained person.
•According to the diagnostic criteria of Japan, the patient has been diagnosed with hypertension, dyslipidemia, or T2DM.
•Participants must have at screening:
•BMI greater than or equal to 27 kg/m2, and two or more obesity-related health disorders.
•BMI greater than or equal to 35 kg/m
•Self-reported attempts of diet/exercise therapy for weight loss in the past, but did not achieve sufficient results.

•Complicated with type 1 diabetes mellitus (T1DM), lifetime history of ketoacidosis or hyperosmolar state/coma.
•Self-reported weight change >5 kg within 3 months prior to screening.
•Individuals with obesity induced by other endocrine disorders(e.g., Cushing's syndrome) or monogenic or syndromic obesity (e.g., melanocortin type 4 receptor deficiency or Prader-Willi syndrome).
•Subjects who have received or plan to receive surgical treatment for obesity in the past. Liposuction or abdominoplasty may be included if it was performed more than one year prior to screening.
•Has a history or combination of significant active or unstable major depressive disorder or other severe psychiatric disorders.
•Has a history of clinically significant gastric emptying abnormalities.
•Has a history of acute or chronic pancreatitis or clinically significant gallbladder disease.
•Has uncontrolled hypertension at screening.
•Subjects with any of the following cardiovascular diseases (Acute myocardial infarction, Cerebrovascular (stroke) /transient ischemic attack, Unstable angina, Hospitalization for heart failure) within 3 months prior to screening.
•Received an approved or under development GLP-1 RA-based therapy (e.g., GLP-1 RA, GLP-1/GIP dual RA) within 6 months prior to randomization.

发起方

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