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

NCT07139405 · Not yet recruiting

Last updated 2026-05-28

This clinical trial compared the effects of TriGlytza® and Metformin on blood sugar control in adults with type 2 diabetes over 24 weeks.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 90 people Planned (estimated).

Who can join Ages 18–70 · all sexes

Timeline Started 2026-02 · est. completion 2028-06

What this study is testing ClinicalTrials.gov NCT07139405 ↗

Description as written by the study sponsor.

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.

Treatments tested

Metformin XR 1000mg Drug

Arm 1: Metformin XR 1000mg Monotherapy (taken AM)
Valsartan 80mg Tablet Drug

Arm 2: Valsartan 80mg (taken PM)
Valsartan 160mg tablet Drug

Arm 3: Valsartan 160mg (taken PM)
Celecoxib (Celebrex®) 100mg Drug

Arm 2: Celecoxib 100mg (taken AM)
Celecoxib (Celebrex®) 200mg Drug

Arm 3: Celecoxib (taken AM)
Metformin XR 500 mg Drug

Arm 2: Metformin 500mg (taken AM)

Main thing measured	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.
Sponsor	Myopharm Limited
Conditions studied	Type 2 Diabetes (T2DM)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07139405 ↗