TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT

NCT07139405 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: MYP-001IND136121
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 diabetes (T2DM) is still very difficult to treat because current medicines mostly help with symptoms but don't stop the damage happening inside the pancreas. Many people who start on common treatments like Metformin, and even newer drugs like Ozempic, eventually stop responding to them. This is because these drugs don't address the real problem: the gradual loss of the pancreas' ability to make insulin and the body's increasing resistance to it. Myopharm is developing a new treatment called TriGlytza®, which combines existing medicines (Celecoxib and Valsartan) with Metformin. This new approach is designed to target the inflammation and biological pathways that cause ongoing damage in Type 2 diabetes, aiming to protect the pancreas and reduce insulin resistance. Early animal studies and past clinical trials with the individual drugs show promising results. The number of people with Type 2 diabetes is expected to double by 2045, and the disease brings huge health and financial costs. It also raises the risk of heart disease, stroke, kidney damage, nerve problems, vision loss, certain cancers, and even conditions like Alzheimer's. Because of this, a treatment that addresses the root causes rather than just symptoms could make a major difference. TriGlytza® aims to provide a safe, affordable, and more effective long-term treatment than current options, helping people manage their diabetes better and avoid related health problems.

Conditions

Type 2 Diabetes (T2DM)

Keywords

Type 2 Diabetes; Diabetes; Metformin; Myopharm; Valsartan; Celecoxcib

Outcome Measures

Primary Outcomes (1)

• To demonstrate that after 24 weeks of treatment, the mean improved change in glycemic response from baseline, measured through mean reduction in HbA1c levels, for TriGlytza™ is superior to Metformin monotherapy.

  Mean change in HbA1c from baseline to Treatment Week 24.

  24 weeks

Study Arms (3)

Arm 1: Metformin XR Monotherapy

ACTIVE COMPARATOR

Metformin extended release, (taken AM), stable dose up to 1000mg daily

Drug: Metformin XR 1000mg

Arm 2: TriGlytza Low Dose

EXPERIMENTAL

TriGlytza low dose includes 500mg Metformin-XR (taken AM), 100mg Celecoxcib (AM), and 80mg Valsartan (taken PM)

Drug: Valsartan 80mg Tablet; Drug: Celecoxib (Celebrex®) 100mg; Drug: Metformin XR 500 mg

Arm 3: TriGlytza High Dose

EXPERIMENTAL

TriGlytza high dose includes 1000mg Metformin-XR (taken AM), 200mg Celecoxcib (AM), and160mg Valsartan (taken PM)

Drug: Metformin XR 1000mg; Drug: Valsartan 160mg tablet; Drug: Celecoxib (Celebrex®) 200mg

Interventions

Metformin XR 1000mg DRUG

Arm 1: Metformin XR 1000mg Monotherapy (taken AM)

Arm 1: Metformin XR Monotherapy; Arm 3: TriGlytza High Dose

Valsartan 80mg Tablet DRUG

Arm 2: Valsartan 80mg (taken PM)

Arm 2: TriGlytza Low Dose

Valsartan 160mg tablet DRUG

Arm 3: Valsartan 160mg (taken PM)

Arm 3: TriGlytza High Dose

Celecoxib (Celebrex®) 100mg DRUG

Arm 2: Celecoxib 100mg (taken AM)

Arm 2: TriGlytza Low Dose

Celecoxib (Celebrex®) 200mg DRUG

Arm 3: Celecoxib (taken AM)

Arm 3: TriGlytza High Dose

Metformin XR 500 mg DRUG

Arm 2: Metformin 500mg (taken AM)

Arm 2: TriGlytza Low Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age 18 and ≤70 at time of screening visit
• WOCBP must have negative serum or urine pregnancy test (min sensitivity 25 IU/L or equivalent HCG) within 24 hours prior to the start of the study
• Women must not be breastfeeding
• Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit
• Subjects should have been taking the same daily dose of Metformin for at least 8 weeks prior to the enrolment visit and subjects must not receive other antihyperglycemic medications within the 12 weeks prior to screening
• FPG ≥140 mg/dL
• BMI ≥28 and ≤40
• Grade 1 hypertension defined as 140-159 systolic and 90-99 diastolic mmHg if patients is not receiving anti-hypertensive medication at the time of screening / or has never received anti-hypertensive medication.
• If patient is receiving anti-hypertensive medication at the time of screening and their BP is controlled, BP should be within the normal range of \<120-139 systolic and \<80-89 diastolic.
• Patients receiving anti-hypertensive medication at the time of screening and for which their hypertension is uncontrolled, will be excluded
• eGFR ≥ 60 ml/min

You may not qualify if:

• Patients with Type 1 Diabetes
• Patients with history of ketoacidosis
• Subjects at serious risk of GI adverse events per the discretion of the study site investigator (e.g current or recent history of GI bleeding ulceration, or perforation)
• Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis
• Subjects with a history of uncontrolled hyperglycemia (\>15.0 mmol/L) after an overnight fast that required rescue therapy
• Impaired kidney function defined as eGFR ≤60 mL/min
• Subjects taking any prohibited medications.
• Any of the following cardiovascular (CV)/vascular diseases within 3 months of the screening visit:
• Myocardial infarction (MI)
• Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \[(CABG\]/Percutaneous transluminal coronary angioplasty (PTCA)\]
• Unstable angina
• Unstable congestive heart failure (CHF)
• Transient ischemic attack (TIA) or significant cerebrovascular disease
• Unstable or previously diagnosed arrhythmia
• Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute heart failure and/or known left ventricular ejection fraction of ≤40%.

Sponsors & Collaborators

• Myopharm Limited: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Valsartan; Tablets; Celecoxib

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dosage Forms; Pharmaceutical Preparations; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles

Study Officials

• George Tachas

  Myopharm Limited

  STUDY DIRECTOR

Central Study Contacts

Tamara Miller

CONTACT

+61 2 8527 2453; tmiller@myopharm.com

Karinza Phoenix

CONTACT

+61 2 8527 2453; kphoenix@myopharm.com

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: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08