Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07112872

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Obudai Egeszsegugyi Centrum Kft., Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7795081

Drug

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

semaglutide

Drug

Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.

Placebo

Drug

Placebo will be taken orally QD during the 30-week treatment period.

Primary outcomes

  1. RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30

    Time frame: Baseline to Week 30

Secondary outcomes

  1. RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30

    Time frame: Baseline to Week 30

  2. Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30

    Time frame: Week 30

  3. Change in Fasting Plasma Glucose from Baseline at Week 30

    Time frame: Baseline to Week 30

  4. Percent Change in Body Weight from Baseline at Week 30

    Time frame: Baseline to Week 30

  5. Absolute Change in Body Weight (kg) from Baseline at Week 30

    Time frame: Baseline to Week 30

  6. Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30

    Time frame: Baseline and Week 30

  7. Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

    Time frame: From first dose until 28 days after the final dose of study treatment (34 weeks)

  8. Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025)

    Time frame: From first dose until 28 days after the final dose of study treatment (34 weeks)

  9. Plasma Concentrations of RO7795081 at Prespecified Timepoints

    Time frame: Predose on Day 1 and at prespecified timepoints until Week 30

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.