NCT07139405Not yet recruitingPhase 2
TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 17 Aug 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Myopharm Limited
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07139405
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bariatric surgery or recent treatment with anti-obesity medication.
Other illness
- 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.
Lab values
- Use of prohibited glucose-lowering medications before screening.
Other
- Pregnant or breastfeeding, or unwilling to comply with protocol-required contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UniSC Clinical Trials Coordinator of this site? Confirm its status | Maroochydore | Australia | Unknown status |
| Momentum Sunshine Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Momentum Darlinghurst Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.