Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-04 @ 11:12 PM
Study NCT ID:
NCT07139405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT
Sponsor:
Myopharm Limited
Organization:
Study Overview
Official Title:
A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, PHASE II TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND SUPERIORITY OF TRIGLYTZA® OVER METFORMIN IN PATIENTS WITH INADEQUATE GLYCEMIC CONTROL OVER 24 WEEKS OF TREATMENT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESILIENCE
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.
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.
Detailed Description:
Type 2 diabetes (T2DM) continues to be a major unmet medical need largely due to the currently marketed treatment options not adequately treating the underlying pathophysiology of immune mediated damage to the pancreas.
In real-world clinical practice, first-line therapies with Metformin inadequately control newly diagnosed patients and despite second-line and third-line add-on therapies like Ozempic failure rate continue to be 50% in 2022. These drugs are approved for primarily treating the symptoms of T2DM, Metformin providing short term improvements in insulin sensitivity, and Ozempic stimulating beta cells to make insulin, as indicated by reductions in the HbA1c levels, but not for mitigating the underlying pathophysiology of progressive deterioration of pancreatic beta cell function.
These and other standard prescribed drugs like SGLT2 inhibitors are inadequate in filling one of the most important clinical gaps in the T2DM space: sustained glycemic control via preventing pancreatic beta cell failure and decreasing insulin resistance.
To fill this important gap, Myopharm is developing an innovative patient-centric product: TriGlytza® consisting of Celecoxib, Valsartan treatment add-on to Metformin first-line therapy in diabetes. It is custom-designed to target multiple distinct and overlapping pro-inflammatory signalling pathways along the RAS-IL1b-Cox2-PGE2-EP3 axes that contribute to progressive deterioration of beta cell function and insulin resistance, the core defects observed in T2DM patients. The scientific rationale and the product concept are supported by results obtained from translational animal models of the combination as well as controlled clinical studies with Celecoxib monotherapy and Valsartan monotherapy.
The Type 2 diabetes population is expected to double to over 600 million worldwide by 2045, with the current estimated global economic burden over $2.3 Trillion. The Type 2 diabetes market is expected to be over $58.7B in 2025. The burden of Type 2 diabetes rises substantially with multiple diabetes-related co-morbidities such as coronary artery disease, peripheral arterial disease, stroke, retinopathy, nephropathy, and neuropathy. Additionally, there is 35% increased risk of incidence for cancers such as breast, rectum, pancreas, liver and gall bladder due to T2DM and increased risk of developing Alzheimer's, Parkinson's, and depression in diabetes patients. The link between insulin resistance of the brain cells and Alzheimer's disease is so strong that some have proposed classifying it as Type 3 diabetes.
Unlike the currently marketed treatment options which treat Type 2 diabetes, TriGlytza® is custom designed to treat the disease in the context of these multi-factorial comorbidities and coexisting conditions. This study is designed to show how TriGlytza® is a safe, innovative, and commercially viable superior treatment, differentiated from currently marketed drugs for patients to adequately control their Type 2 diabetes and prevent co-morbidities. TriGlytza® potentially provides an inexpensive and safe option to treat this major unmet medical need.
Results obtained from clinical studies with Type 2 diabetes patients and the translation animal models strongly suggest that TriGlytza® has properties that differentiate it from currently marketed drugs. Its potential to prevent or delay Metformin failure and the observed reduction in risk of insulin dependence in particular warrants evaluation of its superiority over Metformin monotherapy in patients with inadequate glycemic control.
In real-world clinical practice, first-line therapies with Metformin inadequately control newly diagnosed patients and despite second-line and third-line add-on therapies like Ozempic failure rate continue to be 50% in 2022. These drugs are approved for primarily treating the symptoms of T2DM, Metformin providing short term improvements in insulin sensitivity, and Ozempic stimulating beta cells to make insulin, as indicated by reductions in the HbA1c levels, but not for mitigating the underlying pathophysiology of progressive deterioration of pancreatic beta cell function.
These and other standard prescribed drugs like SGLT2 inhibitors are inadequate in filling one of the most important clinical gaps in the T2DM space: sustained glycemic control via preventing pancreatic beta cell failure and decreasing insulin resistance.
To fill this important gap, Myopharm is developing an innovative patient-centric product: TriGlytza® consisting of Celecoxib, Valsartan treatment add-on to Metformin first-line therapy in diabetes. It is custom-designed to target multiple distinct and overlapping pro-inflammatory signalling pathways along the RAS-IL1b-Cox2-PGE2-EP3 axes that contribute to progressive deterioration of beta cell function and insulin resistance, the core defects observed in T2DM patients. The scientific rationale and the product concept are supported by results obtained from translational animal models of the combination as well as controlled clinical studies with Celecoxib monotherapy and Valsartan monotherapy.
The Type 2 diabetes population is expected to double to over 600 million worldwide by 2045, with the current estimated global economic burden over $2.3 Trillion. The Type 2 diabetes market is expected to be over $58.7B in 2025. The burden of Type 2 diabetes rises substantially with multiple diabetes-related co-morbidities such as coronary artery disease, peripheral arterial disease, stroke, retinopathy, nephropathy, and neuropathy. Additionally, there is 35% increased risk of incidence for cancers such as breast, rectum, pancreas, liver and gall bladder due to T2DM and increased risk of developing Alzheimer's, Parkinson's, and depression in diabetes patients. The link between insulin resistance of the brain cells and Alzheimer's disease is so strong that some have proposed classifying it as Type 3 diabetes.
Unlike the currently marketed treatment options which treat Type 2 diabetes, TriGlytza® is custom designed to treat the disease in the context of these multi-factorial comorbidities and coexisting conditions. This study is designed to show how TriGlytza® is a safe, innovative, and commercially viable superior treatment, differentiated from currently marketed drugs for patients to adequately control their Type 2 diabetes and prevent co-morbidities. TriGlytza® potentially provides an inexpensive and safe option to treat this major unmet medical need.
Results obtained from clinical studies with Type 2 diabetes patients and the translation animal models strongly suggest that TriGlytza® has properties that differentiate it from currently marketed drugs. Its potential to prevent or delay Metformin failure and the observed reduction in risk of insulin dependence in particular warrants evaluation of its superiority over Metformin monotherapy in patients with inadequate glycemic control.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IND136121 | OTHER | FDA | View |