New TriGlytza-01 treatment compared with metformin for type 2 diabetes
Tests TriGlytza-01 against metformin in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
Key facts
- Where
- Maroochydore, Melbourne, and Sydney, AustraliaSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes whose blood sugar is still too high on a stable dose of metformin, and who are overweight or obese.
- Age
- 18 to 70 years.
- Sex
- All sexes can join.
- Disease stage
- Confirmed type 2 diabetes with inadequate blood sugar control. HbA1c within the range set by the trial. BMI 25 to 40 kg/m². Adequate kidney function.
- Earlier treatment
- Must be taking a stable dose of metformin. Must not have used prohibited glucose-lowering medicines before screening. No bariatric surgery. No recent anti-obesity medicine.
- Biomarker or test result
- HbA1c within the screening range set by the trial protocol.
Main reasons for not taking part
- Type 1 diabetes or past diabetic ketoacidosis
- Serious kidney, liver, stomach or bowel, heart or other medical conditions
- Recent major heart event or unstable heart disease
- Active infection or another uncontrolled medical condition
- Pregnant or breastfeeding, or unwilling to use the required contraception
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07139405, who can take part
Where in Australia
- UniSC Clinical TrialsMaroochydore, AustraliaContact: Charles Czank, PhD MBANo longer taking part
- Momentum SunshineMelbourne, AustraliaContact: Charles Czank, PhD MBANo longer taking part
- Momentum DarlinghurstSydney, AustraliaContact: Charles Czank, PhD MBANo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Myopharm Limited
- Trial code
- NCT07139405
- Record updated
- 8 July 2026
- Original description
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessedRead full original descriptionShow less
A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed
Inclusion: 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: Previous bariatric surgery or recent treatment with anti-obesity medication; Type 1 diabetes mellitus or history of diabetic ketoacidosis; 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; Active infection or other uncontrolled medical condition; Any condition that, in the investigator's opinion, would make participation unsuitable or compromise the study; Use of prohibited glucose-lowering medications before screening; Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception.