Phase 3 Type 2 Diabetes Trial, Recruiting NCT07351045 Sponsor: Hoffmann-La Roche Condition: Type 2 Diabetes
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Phase 3 Type 2 Diabetes Trial, Recruiting

NCT07351045
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:

  • People whose body mass index (BMI — a measure of body weight relative to height) is 30 or above, OR whose BMI is between 27 and 30 and who also have at least one weight-related health condition, such as prediabetes, high blood pressure, high cholesterol, sleep apnea, or weight-related heart disease.
  • People who have made at least one previous attempt to lose weight through diet or exercise that did not succeed, based on self-report.
  • People who are able to give themselves an injection of the study drug, or who can receive the injection from a trained person if they have a visual impairment or physical limitation.

Who may not be able to join:

  • People with a history of Type 1 or Type 2 diabetes, or a history of diabetic ketoacidosis or hyperosmolar coma (a serious diabetes-related emergency) — though a past diagnosis of gestational diabetes (diabetes during pregnancy) may be acceptable if no diabetes has been recorded since.
  • People whose body weight has changed by more than 5 kg (about 11 pounds) in the three months before screening.
  • People whose weight problems are caused by a hormonal disorder (such as Cushing's syndrome) or by a specific genetic condition linked to obesity (such as Prader-Willi syndrome).
  • People who have previously had, or are planning to have, surgery to treat obesity — though liposuction or a tummy tuck performed more than one year before screening may be acceptable.
  • People with a known significant problem with how their stomach empties food, such as severe gastroparesis (confirm with trial site).
  • People with a history of acute or chronic pancreatitis (inflammation of the pancreas) or significant gallbladder disease — though prior pancreatitis caused by gallstones or gallbladder disease may be acceptable if the gallbladder was surgically removed at least three months before screening.
  • People with poorly controlled high blood pressure at the time of screening.
  • People who have had a heart attack, stroke, mini-stroke (TIA), unstable chest pain (angina), or a hospital stay due to heart failure within the three months before screening.
  • People with a history of significant or unstable major depression, schizophrenia, bipolar disorder, or other serious mood or anxiety disorders — though people with stable major depression or generalised anxiety disorder that has been stable for at least one year may be considered, depending on their medications and the opinion of the trial investigator.
  • People who have been treated with a type of weight-loss or diabetes medication known as a GLP-1 receptor agonist (such as certain injectable medications used for weight management or blood sugar control) within six 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 19 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
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
16 March 2026
Est. completion
24 July 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

3 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: 19 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