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RecruitingPhase 3

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

Boehringer Ingelheim · NCT07754461

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
57
Study start
August 24, 2026
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Placebo; Survodutide

Conditions: Type 2 Diabetes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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, B or C:
  • 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);
  • 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);
  • 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)
  • 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 human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
  • 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

  • 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 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
  • 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 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).
  • 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)
  • Further exclusion criteria apply.

Recruiting US locations

  • Cahaba Research, Inc. - Trussville Location

    Birmingham, AL 35235

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Helios Clinical Research - Paradise Valley

    Paradise Valley, AZ 85253

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Helios Clinical Research - Phoenix

    Phoenix, AZ 85028

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Woodland International Research Group, Inc.

    Little Rock, AR 72211

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • John Muir Physician Network Clinical Research Center

    Concord, CA 94520

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Neighborhood Healthcare - Escondido

    Escondido, CA 92025

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Trials Research - Lincoln

    Lincoln, CA 95648

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ARK Clinical Research

    Long Beach, CA 90815

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Valley Clinical Trials, Inc.

    Northridge, CA 91325

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Fomat Medical Research

    Oxnard, CA 93030

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Encompass Clinical Research, Spring Valley

    Spring Valley, CA 91978

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Diablo Clinical Research

    Walnut Creek, CA 94598

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Focus Clinical Research

    West Hills, CA 91307

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Research of West Florida, Inc.

    Clearwater, FL 33765

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Northeast Research Institute

    Fleming Island, FL 32003

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Fort Myers

    Fort Myers, FL 33912

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Encore Medical Research

    Hollywood, FL 33024

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Northeast Research Institute

    Jacksonville, FL 32204

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Accel Research Sites - Lakeland

    Lakeland, FL 33803

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Research of Central Florida - Lakeland

    Lakeland, FL 33805

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Tampa Bay Medical Research - Largo

    Largo, FL 33777

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • New Horizon Research Center-Miami-69732

    Miami, FL 33165

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Brandon

    Riverview, FL 33578

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Sarasota

    University Park, FL 34201

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Encore Medical Research - Weston

    Weston, FL 33331

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Conquest Research

    Winter Park, FL 32789

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Centricity Research, Endocrine Consultants

    Columbus, GA 31904

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Javara-Fayetteville-67354

    Fayetteville, GA 30214

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Elite Clinical Trials - Blackfoot

    Blackfoot, ID 83221

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cotton O'Neil Mulvane

    Topeka, KS 66606

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • AMR Lexington

    Lexington, KY 40509

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Revival Research Institute, LLC - Dearborn

    Dearborn, MI 48126

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Arcturus Healthcare - Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Olive Branch Family Medical Center

    Olive Branch, MS 38654

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • StudyMetrix Research, LLC

    City of Saint Peters, MO 63303

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Ellipsis Research Group - Brooklyn

    Brooklyn, NY 11215

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Javara Inc. - Cape Fear Valley Medical Center

    Fayetteville, NC 28304

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • PharmQuest Life Sciences

    Greensboro, NC 27408

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Centricity Research - Morehead City

    Morehead City, NC 28557

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Diabetes & Endocrinology Associates of Stark County

    Canton, OH 44718

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Advanced Medical Research - Maumee

    Maumee, OH 43537

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • New Venture Medical Research

    Wadsworth, OH 44281

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Tekton Research Oklahoma City

    Oklahoma City, OK 73134

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Heritage Valley Medical Group

    Beaver, PA 15009

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Preferred Primary Care Physicians-Pittsburgh-63932

    Pittsburgh, PA 15236

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Spartanburg Medical Research

    Spartanburg, SC 29303

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • University Diabetes & Endocrine Consultants

    Chattanooga, TN 37411

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Texas Diabetes and Endocrinology - Central Austin

    Austin, TX 78731

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • South Texas Research Institute - Brownsville

    Brownsville, TX 78520

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Privia Medical Group Gulf Coast, PLLC

    Conroe, TX 77384

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Pinnacle Clinical Research - Georgetown

    Georgetown, TX 78626

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Juno Research, LLC

    Houston, TX 77040

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Biopharma Informatic, Inc. Research Center

    Houston, TX 77084

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Pinnacle Clinical Research - San Antonio

    San Antonio, TX 78222

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Pinnacle Clinical Research, LLC

    San Antonio, TX 78229

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Olympus Family Medicine

    Salt Lake City, UT 84117

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ERA Health Research - Redmond

    Redmond, WA 98052

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
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