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

September 16, 2026 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Not yet recruiting
        • Royal Prince Alfred Hospital
        • Contact:
    • Queensland
      • Meadowbrook, Queensland, Australia, 4131
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Not yet recruiting
        • Southern Adelaide Diabetes & Endocrine services
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • Baker Heart and Diabetes Institute
        • Contact:
  • Canada
      • Québec, Canada, G1G 5X1
        • Recruiting
        • Recherche Clinique Sigma Inc.
        • Contact:
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Recruiting
        • Centricity Research (Brampton)
        • Contact:
      • Concord, Ontario, Canada, L4K 4M2
        • Not yet recruiting
        • Centricity Research (Vaughan)
        • Contact:
      • Nepean, Ontario, Canada, K2J 0V2
        • Not yet recruiting
        • Centricity Research (Nepean)
        • Contact:
      • Toronto, Ontario, Canada, M9V 4B4
        • Not yet recruiting
        • Albion Finch Medical Centre
        • Contact:
      • Toronto, Ontario, Canada, M6G 1M2
        • Not yet recruiting
        • Diabetes Heart Research Centre
        • Contact:
      • Toronto, Ontario, Canada, M4G 3E8
        • Not yet recruiting
        • Centricity Research (Bayview)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4J 1E3
        • Recruiting
        • Endocrinologie Oasis Inc
        • Contact:
      • Montreal, Quebec, Canada, H4A 3T2
        • Not yet recruiting
        • Applied Medical Informatics Research Inc.
        • Contact:
  • India
      • Ahmedabad, India, 380006
        • Not yet recruiting
        • Gujarat Endocrine Centre
        • Contact:
      • Ahmedabad, India, 380006
        • Not yet recruiting
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Contact:
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • AIIMS Bhubaneshwar
        • Contact:
      • Cuttack, India, 753007
        • Not yet recruiting
        • S.C.B. Medical College & Hospital
        • Contact:
      • Hyderabad, Afzalgunj, India, 500012
        • Not yet recruiting
        • Osmania Medical College & Hospital
        • Contact:
      • Kolhāpur, India, 416003
        • Not yet recruiting
        • Shree Mahalaxmi Diatone Institute
        • Contact:
      • Lucknow, India, 226 014
        • Not yet recruiting
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contact:
      • Nagpur, India, 440010
        • Not yet recruiting
        • Diabetes Care and Research Centre
        • Contact:
      • Nashik, India, 422002
        • Not yet recruiting
        • Supe Heart & Diabetes Hospital & Research Centre
        • Contact:
      • New Delhi, India, 110029
        • Not yet recruiting
        • AIIMS, New Delhi
        • Contact:
      • Pune, India, 411004
        • Not yet recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contact:
      • Trivandrum, India, 695032
        • Not yet recruiting
        • Jothydev's Diabetes Research Centre
        • Contact:
      • Visakhapatnam, India, 530040
        • Not yet recruiting
        • Vishakha Institute of Medical Sciences
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 0626
      • Hamilton, New Zealand, 3204
    • Christchurch
      • Christchurch Central City, Christchurch, New Zealand, 8011
        • Not yet recruiting
        • New Zealand Clinical Research (NZCR) Christchurch
        • Contact:
    • Dunedin
      • Central Dunedin, Dunedin, New Zealand, 9016
        • Not yet recruiting
        • Momentum Clinical Research Dunedin
        • Contact:
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Not yet recruiting
        • Cahaba Research, Inc. - Trussville Location
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85296
      • Paradise Valley, Arizona, United States, 85253
        • Not yet recruiting
        • Helios Clinical Research - Paradise Valley
        • Contact:
      • Peoria, Arizona, United States, 85381
      • Phoenix, Arizona, United States, 85028
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Canoga Park, California, United States, 91304
      • Concord, California, United States, 94520
        • Recruiting
        • John Muir Physician Network Clinical Research Center
        • Contact:
      • Escondido, California, United States, 92025
      • Lincoln, California, United States, 95648
      • Long Beach, California, United States, 90815
      • Norco, California, United States, 92860
      • Northridge, California, United States, 91325
      • Oxnard, California, United States, 93030
      • Spring Valley, California, United States, 91978
      • Tustin, California, United States, 92780
        • Not yet recruiting
        • University Clinical Investigators, Inc.
        • Contact:
      • Walnut Creek, California, United States, 94598
      • West Hills, California, United States, 91307
    • Florida
      • Clearwater, Florida, United States, 33765
      • Fleming Island, Florida, United States, 32003
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Contact:
      • Hollywood, Florida, United States, 33024
      • Jacksonville, Florida, United States, 32204
      • Lakeland, Florida, United States, 33803
      • Lakeland, Florida, United States, 33805
        • Not yet recruiting
        • Clinical Research of Central Florida - Lakeland
        • Contact:
      • Largo, Florida, United States, 33777
      • Miami, Florida, United States, 33165
        • Not yet recruiting
        • New Horizon Research Center-Miami-69732
        • Contact:
      • Miramar, Florida, United States, 33027
      • Riverview, Florida, United States, 33578
      • University Park, Florida, United States, 34201
        • Recruiting
        • Covenant Metabolic Specialists, LLC - Sarasota
        • Contact:
      • West Palm Beach, Florida, United States, 33401
      • Weston, Florida, United States, 33331
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Columbus, Georgia, United States, 31904
      • Fayetteville, Georgia, United States, 30214
      • Lawrenceville, Georgia, United States, 30046
      • Union City, Georgia, United States, 30291
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Idaho
      • Blackfoot, Idaho, United States, 83221
      • Idaho Falls, Idaho, United States, 83404
      • Meridian, Idaho, United States, 83646
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Not yet recruiting
        • Evanston Premier Healthcare Research LLC
        • Contact:
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Maryland
      • Rockville, Maryland, United States, 20852
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Not yet recruiting
        • Northern Pines Health Center - Buckley
        • Contact:
      • Dearborn, Michigan, United States, 48126
      • Troy, Michigan, United States, 48098
        • Not yet recruiting
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
      • Ridgeland, Mississippi, United States, 39157
        • Not yet recruiting
        • SKY Clinical Research Network Group - Ridgeland
        • Contact:
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
    • Montana
      • Kalispell, Montana, United States, 59901
      • Missoula, Montana, United States, 59804
    • Nevada
      • Las Vegas, Nevada, United States, 89128
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • Brooklyn, New York, United States, 11215
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Not yet recruiting
        • Javara Inc. - Cape Fear Valley Medical Center
        • Contact:
      • Greensboro, North Carolina, United States, 27408
      • Morehead City, North Carolina, United States, 28557
    • Ohio
      • Canton, Ohio, United States, 44718
        • Not yet recruiting
        • Diabetes & Endocrinology Associates of Stark County
        • Contact:
      • Maumee, Ohio, United States, 43537
      • Wadsworth, Ohio, United States, 44281
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Pittsburgh, Pennsylvania, United States, 15236
        • Not yet recruiting
        • Preferred Primary Care Physicians-Pittsburgh-63932
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15243
      • Uniontown, Pennsylvania, United States, 15401
        • Not yet recruiting
        • Preferred Primary Care Physicians - Matthew Drive
        • Contact:
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Not yet recruiting
        • PanAmerican Clinical Research - Bluffton
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
      • Memphis, Tennessee, United States, 38115
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Diabetes and Endocrinology - Central Austin
        • Contact:
      • Brownsville, Texas, United States, 78520
        • Not yet recruiting
        • South Texas Research Institute - Brownsville
        • Contact:
      • Conroe, Texas, United States, 77384
      • Dallas, Texas, United States, 75390-8837
        • Not yet recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
      • Georgetown, Texas, United States, 78626
      • Houston, Texas, United States, 77040
      • Houston, Texas, United States, 77084
        • Not yet recruiting
        • Biopharma Informatic, Inc. Research Center
        • Contact:
      • Houston, Texas, United States, 77089
      • Mesquite, Texas, United States, 75149
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78222
      • Shavano Park, Texas, United States, 78231
      • Weslaco, Texas, United States, 78596
    • Utah
      • Salt Lake City, Utah, United States, 84117
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Not yet recruiting
        • Tidewater Physicians Multispecialty Group
        • Contact:
    • Washington
      • Redmond, Washington, United States, 98052
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Not yet recruiting
        • Clinical Investigation Specialists, Inc.-Kenosha-69111
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Part A: Placebo
Placebo as an add-on to diet and exercise.
Drug: Placebo
Placebo
Experimental: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906
Experimental: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906
Placebo Comparator: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Drug: Placebo
Placebo
Experimental: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906
Experimental: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906
Placebo Comparator: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Placebo
Placebo
Experimental: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906
Experimental: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Drug: Survodutide
Survodutide
Other Names:
  • BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Time Frame: At baseline and Week 41.
At baseline and Week 41.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Time Frame: At baseline and Week 41.
At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Time Frame: At Week 41.
At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Time Frame: At baseline and Week 53.
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Time Frame: At baseline and Week 53.
At baseline and Week 53.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2026

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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