Phase 3 Type 2 Diabetes Trial, Recruiting NCT07351058 Sponsor: Hoffmann-La Roche Condition: Type 2 Diabetes
Back to Type 2 Diabetes

Phase 3 Type 2 Diabetes Trial, Recruiting

NCT07351058
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are able to give yourself the study drug by injection, or have someone trained to help you if you have vision or physical limitations
  • You have been diagnosed with type 2 diabetes, your HbA1c (a measure of average blood sugar) is between 6.5% and 10%, and you have been on a stable diabetes pill regimen for at least 3 months before the study starts (if you take any medication) — note that certain diabetes medications called DPP-4 inhibitors or GLP-1 drugs are not allowed
  • Your Body Mass Index (BMI) — a measure of body weight relative to height — is 27.0 or above
  • You have tried at least once in the past to lose weight through diet and/or exercise without lasting success

Who may not be able to join:

  • You have type 1 diabetes, have ever had a dangerous blood sugar crisis called ketoacidosis, or have had a severe high blood sugar episode in the past 12 months
  • You have had one or more serious low blood sugar episodes, or you do not feel warning signs when your blood sugar drops too low, within the past 6 months
  • Your fasting blood sugar was very high (above 270 mg/dL) on two separate days during the screening period
  • Your body weight has changed by more than 5 kg (about 11 pounds) in the 3 months before the study
  • Your weight problems are caused by another hormonal condition (such as Cushing's syndrome) or a specific genetic condition linked to obesity (such as Prader-Willi syndrome)
  • You have had weight-loss surgery in the past, or are planning to have it (minor cosmetic procedures done more than 1 year ago may be allowed — confirm with trial site)
  • You have a known serious problem with how your stomach empties food, such as severe gastroparesis (confirm with trial site)
  • Your blood pressure is poorly controlled at the time of screening
  • You have had a heart attack, stroke, unstable chest pain, or been hospitalised for heart failure within the 3 months before the study
  • You have used any GLP-1-based diabetes or weight-loss medication (such as semaglutide or tirzepatide) within the 6 months before joining the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S. Only)

Australian sites

Paratus Clinical Western Sydney, Blacktown, New South Wales
Royal Prince Alfred Hospital, Camperdown, New South Wales
Logan Hospital, Meadowbrook, Queensland
Southern Adelaide Diabetes and Endocrine Services (SADES), Oaklands Park, South Australia
Baker Heart and Diabetes Insitute, Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
23 March 2026
Est. completion
7 August 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland Puerto Rico 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent (%) Change from Baseline in Body Weight at Week 72

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov