Type 2 Diabetes study: Survodutide
Official title A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
ClinicalTrials.gov ID: NCT07754461
What this study is testing
What is Survodutide?
an investigational once‑weekly injectable medicine being studied as a potential treatment for type 2 diabetes
Also referred to as BI 456906.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares survodutide with a placebo to see if it improves blood sugar control in people with type 2 diabetes.
- Who it's for
- Adults with type 2 diabetes and a BMI of 23 kg/m² or higher.
- What's involved
- Participants receive weekly injections of either survodutide (at two dose levels) or a placebo, while continuing their usual diabetes treatment. They attend up to 12 clinic visits and receive at least 9 phone calls, with regular blood tests and health checks.
- Time commitment
- The study lasts about 1 year and 2 months, with up to 12 clinic visits and regular phone follow‑ups.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years
- Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to...
- Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of...
- Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)/day with or without stable dose of metformin and/or SGLT2i for 90 days...
- Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
You likely can't join if
- Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R)...
- History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation...
- Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the...
- Body weight change (self-reported) \>5% within 90 days before screening (Visit 1)
See the full eligibility criteria
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years
- Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53...
- Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and/or Maximum tolerated dose of...
- Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)/day with or without stable dose of metformin and/or SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol/mol) and...
- Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
- Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
- Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for...
- In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical...
- Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist/glucose-dependent insulinotropic...
- History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
- Body weight change (self-reported) \>5% within 90 days before screening (Visit 1)
- Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery.
- Answered "yes" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal...
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Camperdown, New South Wales, Australia
- Oaklands Park, South Australia, Australia
- New Westminster, British Columbia, Canada
- Brampton, Ontario, Canada
- Concord, Ontario, Canada
- Nepean, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Canada
- Central Dunedin, Dunedin, New Zealand
- Auckland, New Zealand
- Hamilton, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Camperdown, New South Wales, Australia; Oaklands Park, South Australia, Australia; New Westminster, British Columbia, Canada; Brampton, Ontario, Canada; Concord, Ontario, Canada; Nepean, Ontario, Canada and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.