Recruiting
Phase 2

RO7795081

Sponsor:

Hoffmann-La Roche

Code:

NCT07112872

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tifeglipron

Semaglutide

Placebo

Study Details

Brief summary:

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 different doses of tifeglipron for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT07112872

Start date

Aug 19, 2025

Status verified date

Nov, 2026

Completion date

Feb 5, 2028

Anticipated

Primary completion date

Feb 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Part A, Arm 1: Placebo

active comparator: Part A, Arm 2: Semaglutide 14 mg

experimental: Part A, Arm 3: Tifeglipron Dosing Regimen 1

experimental: Part A, Arm 4: Tifeglipron Dosing Regimen 2

experimental: Part A, Arm 5: Tifeglipron Dosing Regimen 3

experimental: Part A, Arm 6: Tifeglipron Dosing Regimen 4

experimental: Part A, Arm 7: Tifeglipron Dosing Regimen 5

experimental: Part A, Arm 8: Tifeglipron Dosing Regimen 6

experimental: Part A, Arm 9: Tifeglipron Dosing Regimen 7

placebo comparator: Part B, Arm 1: Placebo

experimental: Part B, Arm 2: Tifeglipron Dosing Regimen A

experimental: Part B, Arm 3: Tifeglipron Dosing Regimen B

Interventions

Tifeglipron

Tifeglipron will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.

Semaglutide

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

Placebo

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

Primary outcome measure

  • Tifeglipron vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 [ Time Frame: Baseline to Week 30 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BP45703 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Arizona Liver Health - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Prospective Research Innovations Inc.

Recruiting

Rancho Cucamonga, California, United States, 91730

Encompass Clinical Research

Recruiting

Spring Valley, California, United States, 91978

Chase Medical Research

Recruiting

Waterbury, Connecticut, United States, 06708-3346

Emerson Clinical Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20009

Accellacare of Piedmont Healthcare

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare of Wilmington, LLC

Recruiting

Wilmington, North Carolina, United States, 28401

Tristar Clinical Investigations

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.