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

NCT07139405 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-24

No results posted yet for this study

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)

Interventions

DRUG

Metformin XR 1000mg

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

DRUG

Valsartan 80mg Tablet

Arm 2: Valsartan 80mg (taken PM)

DRUG

Valsartan 160mg tablet

Arm 3: Valsartan 160mg (taken PM)

DRUG

Celecoxib (Celebrex®) 100mg

Arm 2: Celecoxib 100mg (taken AM)

DRUG

Celecoxib (Celebrex®) 200mg

Arm 3: Celecoxib (taken AM)

DRUG

Metformin XR 500 mg

Arm 2: Metformin 500mg (taken AM)

Sponsors & Collaborators

  • Myopharm Limited

    lead OTHER

Principal Investigators

  • George Tachas · 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
2026-02-28
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

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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