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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

A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes

Naoto Kubota

Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

Sept. 01, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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:
1. BMI greater than or equal to 27 kg/m2, and two or more obesity-related health disorders.
2. BMI greater than or equal to 35 kg/m2.
-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.

Both

Obesity

RO7795068:RO7795068 will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

efficacy:
Percent (%) change from baseline in body weight at Week 72

safety, efficacy
-Percentage of Participants Achieving >=5%, >=10%, >=15%, >=20%, >=25% Body Weight Loss from Baseline at Week 72
-Change from baseline in waist circumference at Week 72
-Percent change from baseline in body weight at Week 24, 48, 72
-Change from baseline in body weight at Week 24, 48, 72
-Change from baseline in BMI at Week 24, 48, and 72
-EWL at Week 24,48,72
-Percentage of Participants Achieving >=5%, >=10%, >=15%, >=20%, >=25% Body Weight Loss from Baseline at Week 24, 48
-The period from baseline to achieving weight loss of >=5%, >=10%, >=15%, >=20%, and >=25% by Week 72
-Percentage of participants achieving BMI < 25 at Week 72
-Percentage of participants achieving BMI < 27 at Week 72
-Percentage of participants with at least one downgrade in their obesity class at Week 72
-Change from baseline in waist circumference at Week 24, 48, and 72
-Change from baseline in waist-to-hip ratio at Week 24, 48, and 72
-Change from baseline in waist-to-height ratio at Week 24, 48, and 72
-Change from baseline in visceral fat area at week 72 by MRI assessment
-Percentage of participants whose visceral fat area was less than 100 cm2 at week 72 as assessed by MRI
-Change from baseline in VAT and ASAT volume/volume at week 72 by MRI assessment.
-Amount of change from baseline in fasting blood glucose at Week 24, 48, and 72
-Change from baseline in HbA1c at Week 24, 48, 72
-Changes from baseline in diabetes-related, lipid-related, and blood pressure-related tests at weeks 24, 48, and 72
-Change from baseline in CoEQ subscale scores at Week 24, 48, and 72, and individual scores for hunger items
-Amount of change from baseline in physical function as assessed by the physical function domain of the SF-36v2 Acute Form at Week 72
-Change from baseline in composite physical function as assessed by IWQoL-Lite-CT at Week 72
-Change from baseline in HRQoL as assessed by SF-36v2 Acute Form domain score and component summary score at Week 72
-Change from baseline in HRQoL as assessed by IWQoL-Lite-CT domain score and total score at Week72
-Change from baseline in the number of participants with T2DM at Week 72
-Percentage of participants with improved T2DM at Week 72
-Incidence and severity of adverse events up to Week 72.
-Amount of change from baseline in vital signs up to Week 72
-Amount of change from baseline in laboratory test results up to Week 72
-Change from baseline in C-SSRS and PHQ-9 up to Week 72
-Plasma concentration of Enicepatide / RO7795068
-ADA prevalence at baseline and ADA expression during the study period.

+81-42-648-5551

June. 22, 2026

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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