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Clinical Trials in Australia / NCT07139405
Starting soon Phase 2

TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy

NCT07139405 · tracked via the Priya Life Science Australia tracker
Sponsor
Myopharm Limited
Phase
Phase 2
Started
2026-09-01
Last updated
2026-07-08

Condition(s) studied

Type 2 Diabetes (T2DM)

Investigational drug(s) / intervention(s)

Metformin XR →Celecoxib →Valsartan →

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria Adults aged 18 to 70 years. Confirmed diagnosis of Type 2 diabetes mellitus. Inadequate glycaemic control while receiving a stable dose of metformin. Inclusion Criteria: * Adults aged 18 to 70 years. * Confirmed diagnosis of Type 2 diabetes mellitus. * Inadequate glycaemic control while receiving a stable dose of metformin. * HbA1c within the protocol-defined screening range. * Body mass index (BMI) 25 to 40 kg/m². * Adequate renal function. * Able and willing to provide written informed consent and comply with study procedures. Exclusion Criteria: * Type 1 diabetes mellitus or history of diabetic ketoacidosis. * Use of prohibited glucose-lowering medications before screening. * Clinically significant renal, hepatic, gastrointestinal, cardiovascular, or other medical conditions that could interfere with study participation or safety. * Recent major cardiovascular event or unstable cardiovascular disease. * Previous bariatric surgery or recent treatment with anti-obesity medication. * Active infection or other uncontrolled medical condition. * Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception. * Any condition that, in the investigator's opinion, would make participation unsuitable or compromise the study.

Primary outcome measure(s)

  • Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. — 16 weeks

Trial sites (3)

FacilityCityRegionStatus
UniSC Clinical Trials Maroochydore Queensland
Momentum Sunshine Melbourne Victoria
Momentum Darlinghurst Sydney Australia

On this site

📄 Diovan (valsartan) drug profile →
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07139405 on ClinicalTrials.gov ↗ ← All trials in Australia