Clinical trial for Type 2 Diabetes
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?
Survodutide is an investigational medicine, given as an once-weekly pill taken by mouth, 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
- This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join.
- 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
- Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD)...
- 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...
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
- Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A...
- 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. The following are allowed: (1) liposuction and/or abdominoplasty, if...
- 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's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Paradise Valley, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Concord, California, United States
- Escondido, California, United States
- Lincoln, California, United States
- Long Beach, California, United States
- Norco, California, United States
- Northridge, California, United States
- Oxnard, California, United States
- Spring Valley, California, United States
- Tustin, California, United States
- Walnut Creek, California, United States
- West Hills, California, United States
- Clearwater, Florida, United States
- Fleming Island, Florida, United States
+ 92 more site(s).
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Paradise Valley, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States and 106 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.