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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Har ikke rekruttert ennå
        • Royal Prince Alfred Hospital
        • Ta kontakt med:
    • Queensland
      • Meadowbrook, Queensland, Australia, 4131
        • Har ikke rekruttert ennå
        • Logan Hospital
        • Ta kontakt med:
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Har ikke rekruttert ennå
        • Southern Adelaide Diabetes & Endocrine Services
        • Ta kontakt med:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Har ikke rekruttert ennå
        • Baker Heart and Diabetes Institute
        • Ta kontakt med:
  • Canada
      • Québec, Canada, G1G 5X1
        • Har ikke rekruttert ennå
        • Recherche Clinique Sigma Inc.
        • Ta kontakt med:
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Har ikke rekruttert ennå
        • Fraser Clinical Trials
        • Ta kontakt med:
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Har ikke rekruttert ennå
        • Centricity Research (Brampton)
        • Ta kontakt med:
      • Concord, Ontario, Canada, L4K 4M2
        • Har ikke rekruttert ennå
        • Centricity Research (Vaughan)
        • Ta kontakt med:
      • Nepean, Ontario, Canada, K2J 0V2
        • Har ikke rekruttert ennå
        • Centricity Research (Nepean)
        • Ta kontakt med:
      • Toronto, Ontario, Canada, M9V 4B4
        • Har ikke rekruttert ennå
        • Albion Finch Medical Centre
        • Ta kontakt med:
      • Toronto, Ontario, Canada, M6G 1M2
        • Har ikke rekruttert ennå
        • Diabetes Heart Research Centre
        • Ta kontakt med:
      • Toronto, Ontario, Canada, M4G 3E8
        • Har ikke rekruttert ennå
        • Centricity Research (Bayview)
        • Ta kontakt med:
    • Quebec
      • Montreal, Quebec, Canada, H4J 1E3
        • Har ikke rekruttert ennå
        • Endocrinologie Oasis Inc
        • Ta kontakt med:
      • Montreal, Quebec, Canada, H4A 3T2
        • Har ikke rekruttert ennå
        • Applied Medical Informatics Research Inc.
        • Ta kontakt med:
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35235
        • Har ikke rekruttert ennå
        • Cahaba Research, Inc. - Trussville Location
        • Ta kontakt med:
    • Arizona
      • Gilbert, Arizona, Forente stater, 85296
        • Har ikke rekruttert ennå
        • Mission Research Institute - Gilbert
        • Ta kontakt med:
      • Paradise Valley, Arizona, Forente stater, 85253
        • Har ikke rekruttert ennå
        • Helios Clinical Research - Paradise Valley
        • Ta kontakt med:
      • Peoria, Arizona, Forente stater, 85381
        • Har ikke rekruttert ennå
        • Arizona Liver Health - Peoria 85381
        • Ta kontakt med:
      • Phoenix, Arizona, Forente stater, 85028
        • Har ikke rekruttert ennå
        • Helios Clinical Research - Phoenix
        • Ta kontakt med:
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Har ikke rekruttert ennå
        • Woodland International Research Group, Inc.
        • Ta kontakt med:
    • California
      • Canoga Park, California, Forente stater, 91304
        • Har ikke rekruttert ennå
        • San Fernando Valley Health
        • Ta kontakt med:
      • Concord, California, Forente stater, 94520
        • Har ikke rekruttert ennå
        • John Muir Physician Network Clinical Research Center
        • Ta kontakt med:
      • Escondido, California, Forente stater, 92025
        • Har ikke rekruttert ennå
        • Neighborhood Healthcare - Escondido
        • Ta kontakt med:
      • Lincoln, California, Forente stater, 95648
        • Har ikke rekruttert ennå
        • Clinical Trials Research - Lincoln
        • Ta kontakt med:
      • Long Beach, California, Forente stater, 90815
      • Norco, California, Forente stater, 92860
        • Har ikke rekruttert ennå
        • Infinity Clinical Research
        • Ta kontakt med:
      • Northridge, California, Forente stater, 91325
      • Oxnard, California, Forente stater, 93030
        • Har ikke rekruttert ennå
        • Fomat Medical Research
        • Ta kontakt med:
      • Spring Valley, California, Forente stater, 91978
        • Har ikke rekruttert ennå
        • Encompass Clinical Research, Spring Valley
        • Ta kontakt med:
      • Tustin, California, Forente stater, 92780
        • Har ikke rekruttert ennå
        • University Clinical Investigators, Inc.
        • Ta kontakt med:
      • Walnut Creek, California, Forente stater, 94598
      • West Hills, California, Forente stater, 91307
        • Har ikke rekruttert ennå
        • Focus Clinical Research
        • Ta kontakt med:
    • Florida
      • Clearwater, Florida, Forente stater, 33765
        • Rekruttering
        • Clinical Research of West Florida, Inc.
        • Ta kontakt med:
      • Fleming Island, Florida, Forente stater, 32003
        • Har ikke rekruttert ennå
        • Northeast Research Institute
        • Ta kontakt med:
      • Fort Myers, Florida, Forente stater, 33912
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Ta kontakt med:
      • Hollywood, Florida, Forente stater, 33024
        • Har ikke rekruttert ennå
        • Encore Medical Research
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32204
        • Har ikke rekruttert ennå
        • Northeast Research Institute
        • Ta kontakt med:
      • Lakeland, Florida, Forente stater, 33803
        • Har ikke rekruttert ennå
        • Accel Research Sites - Lakeland
        • Ta kontakt med:
      • Lakeland, Florida, Forente stater, 33805
        • Har ikke rekruttert ennå
        • Clinical Research of Central Florida - Lakeland
        • Ta kontakt med:
      • Largo, Florida, Forente stater, 33777
        • Har ikke rekruttert ennå
        • Tampa Bay Medical Research - Largo
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33165
        • Har ikke rekruttert ennå
        • New Horizon Research Center-Miami-69732
        • Ta kontakt med:
      • Miramar, Florida, Forente stater, 33027
        • Har ikke rekruttert ennå
        • South Broward Research
        • Ta kontakt med:
      • Riverview, Florida, Forente stater, 33578
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Brandon
        • Ta kontakt med:
      • University Park, Florida, Forente stater, 34201
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Sarasota
        • Ta kontakt med:
      • West Palm Beach, Florida, Forente stater, 33401
        • Har ikke rekruttert ennå
        • Metabolic Research Institute, Inc.
        • Ta kontakt med:
      • Weston, Florida, Forente stater, 33331
        • Har ikke rekruttert ennå
        • Encore Medical Research - Weston
        • Ta kontakt med:
      • Winter Park, Florida, Forente stater, 32789
    • Georgia
      • Columbus, Georgia, Forente stater, 31904
        • Har ikke rekruttert ennå
        • Centricity Research, Endocrine Consultants
        • Ta kontakt med:
      • Fayetteville, Georgia, Forente stater, 30214
        • Har ikke rekruttert ennå
        • Javara-Fayetteville-67354
        • Ta kontakt med:
      • Lawrenceville, Georgia, Forente stater, 30046
        • Har ikke rekruttert ennå
        • Balanced Life Health Care Solutions
        • Ta kontakt med:
      • Union City, Georgia, Forente stater, 30291
        • Har ikke rekruttert ennå
        • Rophe Adult and Pediatric Medicine
        • Ta kontakt med:
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96817
        • Har ikke rekruttert ennå
        • Pacific Diabetes & Endocrine Center
        • Ta kontakt med:
    • Idaho
      • Blackfoot, Idaho, Forente stater, 83221
        • Har ikke rekruttert ennå
        • Elite Clinical Trials - Blackfoot
        • Ta kontakt med:
      • Idaho Falls, Idaho, Forente stater, 83404
        • Har ikke rekruttert ennå
        • Family First Clinical Research
        • Ta kontakt med:
      • Meridian, Idaho, Forente stater, 83646
        • Har ikke rekruttert ennå
        • Solaris Clinical Research
        • Ta kontakt med:
    • Illinois
      • Skokie, Illinois, Forente stater, 60077
        • Har ikke rekruttert ennå
        • Evanston Premier Healthcare Research LLC
        • Ta kontakt med:
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509
    • Maryland
      • Rockville, Maryland, Forente stater, 20852
        • Har ikke rekruttert ennå
        • Endocrine and Metabolic Consultants
        • Ta kontakt med:
    • Michigan
      • Buckley, Michigan, Forente stater, 49620
        • Har ikke rekruttert ennå
        • Northern Pines Health Center - Buckley
        • Ta kontakt med:
      • Dearborn, Michigan, Forente stater, 48126
        • Har ikke rekruttert ennå
        • Revival Research Institute, LLC - Dearborn
        • Ta kontakt med:
      • Troy, Michigan, Forente stater, 48098
        • Har ikke rekruttert ennå
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Ta kontakt med:
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55416
        • Har ikke rekruttert ennå
        • International Diabetes Center
        • Ta kontakt med:
    • Mississippi
      • Olive Branch, Mississippi, Forente stater, 38654
        • Har ikke rekruttert ennå
        • Olive Branch Family Medical Center
        • Ta kontakt med:
      • Ridgeland, Mississippi, Forente stater, 39157
        • Har ikke rekruttert ennå
        • SKY Clinical Research Network Group - Ridgeland
        • Ta kontakt med:
    • Missouri
      • City of Saint Peters, Missouri, Forente stater, 63303
        • Har ikke rekruttert ennå
        • StudyMetrix Research, LLC
        • Ta kontakt med:
    • Montana
      • Kalispell, Montana, Forente stater, 59901
        • Har ikke rekruttert ennå
        • Logan Health Research - Kalispell
        • Ta kontakt med:
      • Missoula, Montana, Forente stater, 59804
        • Har ikke rekruttert ennå
        • Boeson Research - Missoula
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Har ikke rekruttert ennå
        • Albuquerque Clinical Trials
        • Ta kontakt med:
    • New York
      • Brooklyn, New York, Forente stater, 11215
        • Har ikke rekruttert ennå
        • Ellipsis Research Group - Brooklyn
        • Ta kontakt med:
    • North Carolina
      • Fayetteville, North Carolina, Forente stater, 28304
        • Har ikke rekruttert ennå
        • Cape Fear Valley Medical Center
        • Ta kontakt med:
      • Greensboro, North Carolina, Forente stater, 27408
        • Har ikke rekruttert ennå
        • PharmQuest Life Sciences
        • Ta kontakt med:
      • Morehead City, North Carolina, Forente stater, 28557
        • Har ikke rekruttert ennå
        • Centricity Research - Morehead City
        • Ta kontakt med:
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • Har ikke rekruttert ennå
        • Diabetes & Endocrinology Associates of Stark County
        • Ta kontakt med:
      • Maumee, Ohio, Forente stater, 43537
        • Har ikke rekruttert ennå
        • Advanced Medical Research - Maumee
        • Ta kontakt med:
      • Wadsworth, Ohio, Forente stater, 44281
        • Har ikke rekruttert ennå
        • New Venture Medical Research
        • Ta kontakt med:
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73013
        • Har ikke rekruttert ennå
        • Tekton Research-Edmond-68875
        • Ta kontakt med:
    • Pennsylvania
      • Beaver, Pennsylvania, Forente stater, 15009
        • Har ikke rekruttert ennå
        • Heritage Valley Medical Group
        • Ta kontakt med:
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • Har ikke rekruttert ennå
        • Preferred Primary Care Physicians-Pittsburgh-63932
        • Ta kontakt med:
      • Pittsburgh, Pennsylvania, Forente stater, 15243
        • Har ikke rekruttert ennå
        • Preferred Primary Care Physicians
        • Ta kontakt med:
      • Uniontown, Pennsylvania, Forente stater, 15401
        • Har ikke rekruttert ennå
        • Preferred Primary Care Physicians - Matthew Drive
        • Ta kontakt med:
    • South Carolina
      • Bluffton, South Carolina, Forente stater, 29910
        • Har ikke rekruttert ennå
        • PanAmerican Clinical Research - Bluffton
        • Ta kontakt med:
      • Spartanburg, South Carolina, Forente stater, 29303
        • Har ikke rekruttert ennå
        • Spartanburg Medical Research
        • Ta kontakt med:
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37411
        • Har ikke rekruttert ennå
        • University Diabetes & Endocrine Consultants
        • Ta kontakt med:
      • Memphis, Tennessee, Forente stater, 38115
        • Har ikke rekruttert ennå
        • LifeDoc Research, PLLC
        • Ta kontakt med:
    • Texas
      • Austin, Texas, Forente stater, 78731
      • Brownsville, Texas, Forente stater, 78520
        • Har ikke rekruttert ennå
        • South Texas Research Institute - Brownsville
        • Ta kontakt med:
      • Conroe, Texas, Forente stater, 77384
        • Har ikke rekruttert ennå
        • Privia Medical Group Gulf Coast, PLLC
        • Ta kontakt med:
      • Dallas, Texas, Forente stater, 75390-8837
        • Har ikke rekruttert ennå
        • University of Texas Southwestern Medical Center
        • Ta kontakt med:
      • Georgetown, Texas, Forente stater, 78626
        • Har ikke rekruttert ennå
        • Pinnacle Clinical Research - Georgetown
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77040
      • Houston, Texas, Forente stater, 77084
        • Har ikke rekruttert ennå
        • Biopharma Informatic, Inc. Research Center
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77089
        • Har ikke rekruttert ennå
        • Research Physicians Network
        • Ta kontakt med:
      • Mesquite, Texas, Forente stater, 75149
        • Har ikke rekruttert ennå
        • Southern Endocrinology Associates
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78229
        • Har ikke rekruttert ennå
        • Pinnacle Clinical Research, LLC
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78222
        • Har ikke rekruttert ennå
        • Pinnacle Clinical Research - San Antonio
        • Ta kontakt med:
      • Shavano Park, Texas, Forente stater, 78231
        • Har ikke rekruttert ennå
        • Consano Clinical Research
        • Ta kontakt med:
      • Weslaco, Texas, Forente stater, 78596
        • Har ikke rekruttert ennå
        • Texas Valley Clinical Research
        • Ta kontakt med:
    • Utah
      • Salt Lake City, Utah, Forente stater, 84117
        • Har ikke rekruttert ennå
        • Olympus Family Medicine
        • Ta kontakt med:
    • Virginia
      • Newport News, Virginia, Forente stater, 23606
        • Har ikke rekruttert ennå
        • Tidewater Physicians Multispecialty Group
        • Ta kontakt med:
    • Washington
      • Redmond, Washington, Forente stater, 98052
        • Har ikke rekruttert ennå
        • ERA Health Research - Redmond
        • Ta kontakt med:
    • Wisconsin
      • Kenosha, Wisconsin, Forente stater, 53144
        • Har ikke rekruttert ennå
        • Clinical Investigation Specialists, Inc.-Kenosha-69111
        • Ta kontakt med:
  • India
      • Ahmedabad, India, 380006
        • Har ikke rekruttert ennå
        • Gujarat Endocrine Centre
        • Ta kontakt med:
      • Ahmedabad, India, 380006
        • Har ikke rekruttert ennå
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Ta kontakt med:
      • Bhubaneswar, India, 751019
        • Har ikke rekruttert ennå
        • AIIMS Bhubaneshwar
        • Ta kontakt med:
      • Cuttack, India, 753007
        • Har ikke rekruttert ennå
        • S.C.B. Medical College & Hospital
        • Ta kontakt med:
      • Hyderabad, Afzalgunj, India, 500012
        • Har ikke rekruttert ennå
        • Osmania Medical College & Hospital
        • Ta kontakt med:
      • Kolhāpur, India, 416003
        • Har ikke rekruttert ennå
        • Shree Mahalaxmi DIATONE Institute
        • Ta kontakt med:
      • Lucknow, India, 226 014
        • Har ikke rekruttert ennå
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Ta kontakt med:
      • Nagpur, India, 440010
        • Har ikke rekruttert ennå
        • Diabetes Care and Research Centre
        • Ta kontakt med:
      • Nashik, India, 422002
        • Har ikke rekruttert ennå
        • Supe Heart & Diabetes Hospital & Research Centre
        • Ta kontakt med:
      • New Delhi, India, 110029
        • Har ikke rekruttert ennå
        • AIIMS, New Delhi
        • Ta kontakt med:
      • Pune, India, 411004
        • Har ikke rekruttert ennå
        • Deenanath Mangeshkar Hospital and Research Centre
        • Ta kontakt med:
      • Trivandrum, India, 695032
        • Har ikke rekruttert ennå
        • Jothydev's Diabetes Research Centre
        • Ta kontakt med:
      • Visakhapatnam, India, 530040
        • Har ikke rekruttert ennå
        • Vishakha Institute of Medical Sciences
        • Ta kontakt med:
  • New Zealand
      • Auckland, New Zealand, 0626
        • Har ikke rekruttert ennå
        • Waitemata Clinical Research
        • Ta kontakt med:
      • Hamilton, New Zealand, 3204
        • Har ikke rekruttert ennå
        • Clinical Trials New Zealand Ltd
        • Ta kontakt med:
    • Christchurch
      • Christchurch Central City, Christchurch, New Zealand, 8011
        • Har ikke rekruttert ennå
        • New Zealand Clinical Research (NZCR) Christchurch
        • Ta kontakt med:
    • Dunedin
      • Central Dunedin, Dunedin, New Zealand, 9016
        • Har ikke rekruttert ennå
        • Momentum Clinical Research Dunedin
        • Ta kontakt med:
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Har ikke rekruttert ennå
        • Isis Clinical Research Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Part A: Placebo
Placebo as an add-on to diet and exercise.
Legemiddel: Placebo
Placebo
Eksperimentell: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906
Eksperimentell: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906
Placebo komparator: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Legemiddel: Placebo
Placebo
Eksperimentell: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906
Eksperimentell: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906
Placebo komparator: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Legemiddel: Placebo
Placebo
Eksperimentell: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906
Eksperimentell: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Legemiddel: Survodutide
Survodutide
Andre navn:
  • BI 456906

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Tidsramme: At baseline and Week 41.
At baseline and Week 41.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Tidsramme: At baseline and Week 41.
At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Tidsramme: At Week 41.
At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Tidsramme: 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
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Tidsramme: At baseline and Week 53.
At baseline and Week 53.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. august 2026

Primær fullføring (Antatt)

17. januar 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

5. august 2026

Først innsendt som oppfylte QC-kriteriene

5. august 2026

Først lagt ut (Faktiske)

10. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1404-0115

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere