TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
RESILIENCE-2a
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
2 other identifiers
interventional
48
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2026
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 30, 2027
July 8, 2026
July 1, 2026
1 year
August 17, 2025
July 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
16 weeks
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
Arm 1: Metformin XR Monotherapy
ACTIVE COMPARATORParticipants receive metformin XR 1000-2000 mg/day together with matching placebo capsules and tablets corresponding to celecoxib and valsartan.
Arm 2: TriGlytza Low Dose
EXPERIMENTALParticipants receive metformin XR 1000-2000 mg/day together with celecoxib 100 mg once daily and valsartan 40 mg once daily.
High-dose TriGlytza®-01
EXPERIMENTALParticipants receive metformin XR 1000-2000 mg/day together with celecoxib 200 mg once daily and valsartan 80 mg once daily.
Interventions
Metformin extended-release tablets administered orally once daily according to protocol.
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myopharm Limitedlead
- Southern Star Researchcollaborator
Study Sites (3)
UniSC Clinical Trials
Maroochydore, Queensland, Australia
Momentum Sunshine
Melbourne, Victoria, Australia
Momentum Darlinghurst
Sydney, Australia
Related Publications (3)
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: 21233852BACKGROUNDSeferovic 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: 28330649BACKGROUNDEl-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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Charles Czank
Myopharm Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 24, 2025
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data are not planned to be shared.