Trials Today

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.