A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes (Enith2)

Roche

Status and phase: Begins enrollment this month; Phase 3

Conditions: Obesity or Overweight; Type 2 Diabetes Mellitus

Treatments: Combination Product: RO7795068; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07351058

2025-523106-32-00 (EU Trial (CTIS) Number)

WC45726

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of RO7795068, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,600 participants in 4 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo

Arm 2: RO7795068 Dosing Regimen 1

Experimental group

Treatment:

Combination Product: RO7795068

Arm 3: RO7795068 Dosing Regimen 2

Experimental group

Treatment:

Combination Product: RO7795068

Arm 4: RO7795068 Dosing Regimen 3

Experimental group

Treatment:

Combination Product: RO7795068