Type 2 Diabetes (T2DM)Phase 2RESILIENCE-2aNCT07139405
TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
A Phase 2 study testing Metformin XR, Celecoxib and Valsartan in people with Type 2 Diabetes (T2DM), run by Myopharm Limited at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- Metformin XR, Celecoxib and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Sep 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
UniSC Clinical Trials
Maroochydore, Queensland
Momentum Sunshine
Melbourne, Victoria
Momentum Darlinghurst
Sydney
About this study
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
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
Read the 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.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- Metformin XR, Celecoxib, Valsartan
- Keywords
- Type 2 Diabetes, Diabetes, Metformin, Myopharm, Valsartan, Celecoxcib
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin XRDrug
Metformin extended-release tablets administered orally once daily according to protocol.
CelecoxibDrug
Celecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment.
ValsartanDrug
Valsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Metformin XR Monotherapy | Active comparator | Participants receive metformin XR 1000-2000 mg/day together with matching placebo capsules and tablets corresponding to celecoxib and valsartan. Receives: Drug: Metformin XR |
| Arm 2: TriGlytza Low Dose | Experimental | Participants receive metformin XR 1000-2000 mg/day together with celecoxib 100 mg once daily and valsartan 40 mg once daily. Receives: Drug: Metformin XR; Drug: Celecoxib; Drug: Valsartan |
| High-dose TriGlytza®-01 | Experimental | Participants receive metformin XR 1000-2000 mg/day together with celecoxib 200 mg once daily and valsartan 80 mg once daily. Receives: Drug: Metformin XR; Drug: Celecoxib; Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
Measured: 16 weeks
Secondary outcomes (10)
Change in HbA1c
Measured: 16 weeks
Proportion achieving HbA1c <7.0%
Measured: 16 weeks
Change in fasting plasma glucose
Measured: 16 weeks
Change in body weight
Measured: 16 weeks
Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA)
Change in total body fat (%) measured using whole-body dual-energy X-ray absorptiometry (DEXA).
Measured: 16 weeks
Requirement for rescue therapy
Measured: 16 weeks
Maximum Plasma Concentration (Cmax) of Study Treatment Components
Plasma maximum observed concentration (Cmax)
Measured: 16 weeks
Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components
Time to maximum observed plasma concentration (Tmax)
Measured: 16 weeks
Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components
Plasma area under the concentration-time curve (AUC)
Measured: 16 weeks
Terminal Elimination Half-life (t½) of Study Treatment Components
Plasma terminal elimination half-life (t½)
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myopharm Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Star Research
- Responsible party
- Sponsor
- Investigators
- Charles Czank, Study director, Myopharm Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139405
- Sponsor's protocol ID
- MYP-001
- Other IDs
- IND136121
- Acronym
- RESILIENCE-2a
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
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.
PubMed 21233852Seferovic 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.
PubMed 28330649El-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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07139405
- Acronym / sponsor ID
- RESILIENCE-2a / MYP-001
- Conditions
- Type 2 Diabetes (T2DM)
- Keywords
- Type 2 Diabetes, Diabetes, Metformin, Myopharm, Valsartan, Celecoxcib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Myopharm LimitedUniversity, hospital or other
- Collaborators
- Southern Star Research
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Metformin XR Monotherapy | Active comparator | Drug: Metformin XRParticipants 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: ValsartanParticipants 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: ValsartanParticipants receive metformin XR 1000-2000 mg/day together with celecoxib 200 mg once daily and valsartan 80 mg once daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin XRMetformin extended-release tablets administered orally once daily according to protocol. | Drug | Arm 1: Metformin XR Monotherapy, Arm 2: TriGlytza Low Dose, High-dose TriGlytza®-01 |
| CelecoxibCelecoxib capsules or matching placebo capsules administered orally once daily according to randomized treatment assignment. | Drug | Arm 2: TriGlytza Low Dose, High-dose TriGlytza®-01 |
| ValsartanValsartan tablets or matching placebo tablets administered orally once daily according to randomized treatment assignment. | Drug | Arm 2: TriGlytza Low Dose, High-dose TriGlytza®-01 |
Primary outcome
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16.
Time frame: 16 weeks
10 secondary outcomes
Change in HbA1c
Time frame: 16 weeks
Proportion achieving HbA1c <7.0%
Time frame: 16 weeks
Change in fasting plasma glucose
Time frame: 16 weeks
Change in body weight
Time frame: 16 weeks
Change from Baseline to Week 16 in Total Body Fat Percentage Measured by Dual-energy X-ray Absorptiometry (DEXA)
Time frame: 16 weeks
Requirement for rescue therapy
Time frame: 16 weeks
Maximum Plasma Concentration (Cmax) of Study Treatment Components
Time frame: 16 weeks
Time to Maximum Plasma Concentration (Tmax) of Study Treatment Components
Time frame: 16 weeks
Area Under the Plasma Concentration-Time Curve (AUC) of Study Treatment Components
Time frame: 16 weeks
Terminal Elimination Half-life (t½) of Study Treatment Components
Time frame: 16 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 21233852Donath 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.
- Background: PubMed 28330649Seferovic 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.
- BackgroundEl-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.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
Related trials for Type 2 Diabetes (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Czank study director
Myopharm Limited
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin XR, Celecoxib and Valsartan in people with Type 2 Diabetes (T2DM), run by Myopharm Limited at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Czank, PhD MBA (+61 2 8527 2453, cczank@myopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events and changes in clinical safety assessments through Week 16. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07139405, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.