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

Purpose

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).

Condition

Type 2 Diabetes Mellitus

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Arm 1: Placebo		Drug: Placebo Placebo will be taken orally QD during the 30-week treatment period.
Active Comparator Arm 2: Semaglutide 14 mg		Drug: Semaglutide Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Experimental Arm 3: RO7795081 Dosing Regimen 1		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 4: RO7795081 Dosing Regimen 2		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 5: RO7795081 Dosing Regimen 3		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 6: RO7795081 Dosing Regimen 4		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 7: RO7795081 Dosing Regimen 5		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 8: RO7795081 Dosing Regimen 6		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652
Experimental Arm 9: RO7795081 Dosing Regimen 7		Drug: RO7795081 RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. Other names: CT-996 RG6652

Recruiting Locations

More Details

NCT ID: NCT07112872
Status: Active, not recruiting
Sponsor: Hoffmann-La Roche