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TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
Sponsor: Myopharm Limited
Summary
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
Official title: A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-09-01
Completion Date
2027-12-30
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
Metformin XR
Metformin extended-release tablets administered orally once daily according to protocol.
Celecoxib
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
Valsartan
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
Locations (3)
UniSC Clinical Trials
Maroochydore, Queensland, Australia
Momentum Sunshine
Melbourne, Victoria, Australia
Momentum Darlinghurst
Sydney, Australia