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RecruitingPhase 3

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 12 visits
  • Time periods mentioned: 1 year
  • Procedures mentioned: Injections, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week."
  • "Participants are in the study for about 1 year and 2 months."
  • "During this time, they attend up to 12 visits at the site and receive at least 9 phone calls."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether survodutide helps adults with type 2 diabetes control their blood sugar. It is for people with a BMI of 23 or higher. For about 14 months, participants take weekly shots of survodutide or a placebo (a shot with no medicine) while continuing their usual diabetes care.

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. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and old enough to give legal consent in your country. Sign a form agreeing to join.
  • Have type 2 diabetes and meet the rules for one of the three groups below.
  • Part A: Never used insulin and used no diabetes medicine for at least 90 days. HbA1c, a measure of average blood sugar, must be at least 7.0% but below 9.5%.
  • Part B: Taken steady doses of metformin, sulfonylurea, an SGLT2 inhibitor, or a mix of these diabetes pills for 90 days, at the highest doses you can tolerate. HbA1c must be at least 7.0% but below 10.5%.
  • Part C: Used a steady dose of long-acting insulin of at least 20 units daily for 90 days. Any metformin or SGLT2 inhibitor doses must also be steady. HbA1c must be at least 7.0% but below 10.5%.
  • Have a BMI of at least 23. BMI is a measure based on height and weight.
  • If you can become pregnant, be willing and able to use highly effective birth control.
  • Be willing and able to give yourself shots or get help from a trained person. Follow study steps, including food and exercise advice, keeping a diary, and answering questions.

Who can't join

  • Have type 1 diabetes or LADA, a form of diabetes in adults caused by the immune system.
  • Used diabetes medicines not allowed for your study group, experimental blood sugar drugs, or weight-loss medicines within 90 days before screening or before group assignment.
  • Had a dangerous high-blood-sugar crisis or related coma in the past 6 months, or severe low blood sugar in the past 3 months, through group assignment. Not being able to notice low blood sugar also rules you out.
  • Have diabetes-related eye damage that needs treatment now or is likely to need treatment during the study.
  • Your weight changed by more than 5% in the 90 days before screening.
  • Had or plan to have weight-loss surgery or a weight-loss device. Some exceptions apply for certain procedures done, or devices removed, more than 1 year before screening.
  • Reported a suicide attempt, steps toward an attempt, or self-harm without suicidal intent in the past 2 years, through group assignment.
  • Other rules may also prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: 1. 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 2. 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, B or C: 1. 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 mmol/mol) and \<9.5% (\<80 mmol/mol) as measured by the central laboratory at screening (Visit 1); 2. 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 sulfonylurea and/or Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol/mol) and \<10.5% (\<91 mmol/mol) as measured by the central laboratory at screening (Visit 1); 3. 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 \<10.5% (\<91 mmol/mol) as measured by the central laboratory at screening (Visit 1) 3. Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1) 4. 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 5. 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 human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. 6. 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 limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU) Exclusion criteria: 1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA) 2. 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 polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion/naltrexone, orlistat, phentermine, and phentermine/topiramate 3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2) 4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2) 5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study 6. Body weight change (self-reported) \>5% within 90 days before screening (Visit 1) 7. 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 performed \>1 year before screening (Visit 1), (2) lap banding, if the band has been removed \>1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed \>1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening (Visit 1). 8. 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 Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2) 9. Further exclusion criteria apply.

Study sites (88)

AL

AR

AZ

CA

FL

GA

HI

ID

IL

KS

KY

MD

MI

MN

MO

MS

MT

NC

NM

NY

OH

OK

PA

SC

TN

TX

UT

VA

WA

WI