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

NCT07139405 — Phase 2, Not yet recruiting, 48 participants, Myopharm Limited

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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

Registry	NCT07139405, acronym RESILIENCE-2a
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	48 (Estimated)
Sponsor	Myopharm Limited (Other); collaborators: Southern Star Research
Conditions	Type 2 Diabetes (T2DM)
Interventions	Metformin XR, Celecoxib, Valsartan (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-12-30 (estimated), first posted 2025-08-24, last updated 2026-07-08
Locations	3 sites in Australia

-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

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+Detailed description

This is a multicentre, randomized, double-blind, active-controlled Phase 2a study evaluating TriGlytza®-01 in adults with Type 2 diabetes inadequately controlled on metformin therapy. Eligible participants will be randomized in a 1:1:1 ratio to metformin alone, low-dose TriGlytza®-01, or high-dose TriGlytza®-01. Treatment will continue for 16 weeks following screening. The study will evaluate safety, tolerability, glycaemic efficacy, body weight, pharmacokinetics, and selected metabolic biomarkers.

+Arms and interventions

Arm	Type	Interventions	Description
Arm 1: Metformin XR Monotherapy	Active comparator	Drug: Metformin XR	Participants receive metformin XR 1000-2000 mg/day together with matching placebo capsules and tablets corresponding to celecoxib and valsartan.
Arm 2: TriGlytza Low Dose	Experimental	Drug: Metformin XR; Drug: Celecoxib; Drug: Valsartan	Participants receive metformin XR 1000-2000 mg/day together with celecoxib 100 mg once daily and valsartan 40 mg once daily.
High-dose TriGlytza®-01	Experimental	Drug: Metformin XR; Drug: Celecoxib; Drug: Valsartan	Participants receive metformin XR 1000-2000 mg/day together with celecoxib 200 mg once daily and valsartan 80 mg once daily.

Metformin XR (Drug): Metformin extended-release tablets administered orally once daily according to protocol.
Celecoxib (Drug): Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
Valsartan (Drug): Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Change in HbA1c [16 weeks]
Proportion achieving HbA1c <7.0% [16 weeks]
Change in fasting plasma glucose [16 weeks]
Change in body weight [16 weeks]
Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA) [16 weeks]: Change in total body fat (%) measured using whole-body dual-energy X-ray absorptiometry (DEXA).
Requirement for rescue therapy [16 weeks]
Maximum Plasma Concentration (Cmax) of Study Treatment Components [16 weeks]: Plasma maximum observed concentration (Cmax)
Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components [16 weeks]: Time to maximum observed plasma concentration (Tmax)
Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components [16 weeks]: Plasma area under the concentration-time curve (AUC)
Terminal Elimination Half-life (t½) of Study Treatment Components [16 Weeks]: Plasma terminal elimination half-life (t½)

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (3)

Facility	City	Country
UniSC Clinical Trials	Maroochydore, Queensland	Australia
Momentum Sunshine	Melbourne, Victoria	Australia
Momentum Darlinghurst	Sydney	Australia

+Publications

Donath MY, Shoelson SE. Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 2011 Feb;11(2):98-107. doi: 10.1038/nri2925. Epub 2011 Jan 14. PMID 21233852
Seferovic JP, Claggett B, Seidelmann SB, Seely EW, Packer M, Zile MR, Rouleau JL, Swedberg K, Lefkowitz M, Shi VC, Desai AS, McMurray JJV, Solomon SD. Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2017 May;5(5):333-340. doi: 10.1016/S2213-8587(17)30087-6. Epub 2017 Mar 18. PMID 28330649
El-Bahrawy H, Hegazy S, Farrag W, Werida R. Targeting inflammation using celecoxib with glimepiride in the treatment of obese type 2 diabetic Egyptian patients. Int J Diabetes Dev Ctries. 2015.

+Investigators

Charles Czank, Study director, Myopharm Limited