Triple-Drug combo aims to improve diabetes control and weight loss
NCT ID NCT07139405
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Momentum Darlinghurst
Sydney, Australia
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Momentum Sunshine
Melbourne, Victoria, Australia
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UniSC Clinical Trials
Maroochydore, Queensland, Australia
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