NCT07112872 · Hoffmann-La Roche
A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
What this study is about
This conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, placebo- and where both patients and doctors know the treatment given active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the effectiveness, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).
View original scientific description
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).
Interventions
DRUG
Tifeglipron
Tifeglipron will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
DRUG
Semaglutide
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
DRUG
Placebo
Placebo matching tifeglipron will be taken orally QD during the 30-week treatment period.
Primary outcome measures
Tifeglipron vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Time frame: Baseline to Week 30
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, orth
Where
- Tucson, Arizona
- Lake Forest, California
- Rancho Cucamonga, California
- Spring Valley, California
- Waterbury, Connecticut
- Washington D.C., District of Columbia
- Clermont, Florida
- Pembroke Pines, Florida
- Union City, Georgia
- Oak Lawn, Illinois
- Butte, Montana
- Cedarhurst, New York
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2026 · Source of record for eligibility and locations