Triple-Drug combo aims to improve diabetes control and weight loss

NCT ID NCT07139405

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests a new combination drug called TriGlytza-01 in overweight adults with type 2 diabetes whose blood sugar is not well controlled by metformin alone. The trial compares TriGlytza-01 to standard metformin over 16 weeks, measuring safety, blood sugar levels, and body weight. Participants are randomly assigned to one of three groups and take daily pills. The goal is to see if this triple-drug approach can offer better diabetes management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TriGlytza-01 (a combination of metformin, celecoxib, and valsartan)
What this could lead to
If successful, this could offer a new combination treatment option for people with type 2 diabetes who need better blood sugar control and weight management.
What could go wrong
This is an early Phase 2a trial with only 48 participants, so results may not apply to everyone. The combination includes drugs with known side effects, and it may not prove more effective than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Adults aged 18 to 70 years. Confirmed diagnosis of Type 2 diabetes mellitus. Inadequate glycaemic control while receiving a stable dose of metformin. Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Momentum Darlinghurst

    Sydney, Australia

  • Momentum Sunshine

    Melbourne, Victoria, Australia

  • UniSC Clinical Trials

    Maroochydore, Queensland, Australia

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