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

NCT07139405 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-08

No results posted yet for this 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

Conditions

  • Type 2 Diabetes (T2DM)

Interventions

DRUG

Metformin XR

Metformin extended-release tablets administered orally once daily according to protocol.

DRUG

Celecoxib

Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.

DRUG

Valsartan

Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.

Sponsors & Collaborators

  • Southern Star Research

    collaborator INDUSTRY

  • Myopharm Limited

    lead OTHER

Principal Investigators

  • Charles Czank · Myopharm Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-12-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139405 on ClinicalTrials.gov