A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes

Roche

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Semaglutide; Drug: Placebo; Drug: RO7795081

Study type: Interventional

Funder types: Industry

Identifiers

NCT07112872

BP45703

2024-520322-11-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This multicenter, randomized, double-blind, placebo- and open-label active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
• Have an HbA1c ≥7% and ≤10.5% at screening
• Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
• Body mass index (BMI) ≥23.0 kg/m^2 at screening
• A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)

Exclusion criteria

• Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
• Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
• History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
• Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
• Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
• Have 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)
• Have a known, clinically significant gastric emptying abnormality
• Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 9 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 2: Semaglutide 14 mg

Active Comparator group

Treatment:

Drug: Semaglutide

Arm 3: RO7795081 Dosing Regimen 1

Experimental group

Treatment:

Drug: RO7795081

Arm 4: RO7795081 Dosing Regimen 2

Experimental group

Treatment:

Drug: RO7795081

Arm 5: RO7795081 Dosing Regimen 3

Experimental group

Treatment:

Drug: RO7795081

Arm 6: RO7795081 Dosing Regimen 4

Experimental group

Treatment:

Drug: RO7795081

Arm 7: RO7795081 Dosing Regimen 5

Experimental group

Treatment:

Drug: RO7795081

Arm 8: RO7795081 Dosing Regimen 6

Experimental group

Treatment:

Drug: RO7795081

Arm 9: RO7795081 Dosing Regimen 7

Experimental group

Treatment:

Drug: RO7795081