Hoffmann-La Roche
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).
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…
Tifeglipron will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Placebo matching tifeglipron will be taken orally QD during the 30-week treatment period.