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

16 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Aún no reclutando
        • Royal Prince Alfred Hospital
        • Contacto:
    • Queensland
      • Meadowbrook, Queensland, Australia, 4131
        • Aún no reclutando
        • Logan Hospital
        • Contacto:
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Aún no reclutando
        • Southern Adelaide Diabetes & Endocrine services
        • Contacto:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Aún no reclutando
        • Baker Heart and Diabetes Institute
        • Contacto:
  • Canadá
      • Québec, Canadá, G1G 5X1
        • Reclutamiento
        • Recherche Clinique Sigma Inc.
        • Contacto:
    • British Columbia
      • New Westminster, British Columbia, Canadá, V3L 3W4
        • Reclutamiento
        • Fraser Clinical Trials
        • Contacto:
    • Ontario
      • Brampton, Ontario, Canadá, L6S 0C6
        • Reclutamiento
        • Centricity Research (Brampton)
        • Contacto:
      • Concord, Ontario, Canadá, L4K 4M2
        • Aún no reclutando
        • Centricity Research (Vaughan)
        • Contacto:
      • Nepean, Ontario, Canadá, K2J 0V2
        • Aún no reclutando
        • Centricity Research (Nepean)
        • Contacto:
      • Toronto, Ontario, Canadá, M9V 4B4
        • Aún no reclutando
        • Albion Finch Medical Centre
        • Contacto:
      • Toronto, Ontario, Canadá, M6G 1M2
        • Aún no reclutando
        • Diabetes Heart Research Centre
        • Contacto:
      • Toronto, Ontario, Canadá, M4G 3E8
        • Aún no reclutando
        • Centricity Research (Bayview)
        • Contacto:
    • Quebec
      • Montreal, Quebec, Canadá, H4J 1E3
        • Reclutamiento
        • Endocrinologie Oasis Inc
        • Contacto:
      • Montreal, Quebec, Canadá, H4A 3T2
        • Aún no reclutando
        • Applied Medical Informatics Research Inc.
        • Contacto:
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35235
        • Aún no reclutando
        • Cahaba Research, Inc. - Trussville Location
        • Contacto:
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85296
        • Aún no reclutando
        • Mission Research Institute - Gilbert
        • Contacto:
      • Paradise Valley, Arizona, Estados Unidos, 85253
        • Aún no reclutando
        • Helios Clinical Research - Paradise Valley
        • Contacto:
      • Peoria, Arizona, Estados Unidos, 85381
        • Aún no reclutando
        • Arizona Liver Health - Peoria 85381
        • Contacto:
      • Phoenix, Arizona, Estados Unidos, 85028
        • Aún no reclutando
        • Helios Clinical Research - Phoenix
        • Contacto:
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72211
        • Reclutamiento
        • Woodland International Research Group, Inc.
        • Contacto:
    • California
      • Canoga Park, California, Estados Unidos, 91304
        • Aún no reclutando
        • San Fernando Valley Health
        • Contacto:
      • Concord, California, Estados Unidos, 94520
        • Reclutamiento
        • John Muir Physician Network Clinical Research Center
        • Contacto:
      • Escondido, California, Estados Unidos, 92025
        • Aún no reclutando
        • Neighborhood Healthcare - Escondido
        • Contacto:
      • Lincoln, California, Estados Unidos, 95648
        • Aún no reclutando
        • Clinical Trials Research - Lincoln
        • Contacto:
      • Long Beach, California, Estados Unidos, 90815
        • Reclutamiento
        • ARK Clinical Research
        • Contacto:
      • Norco, California, Estados Unidos, 92860
        • Aún no reclutando
        • Infinity Clinical Research
        • Contacto:
      • Northridge, California, Estados Unidos, 91325
        • Reclutamiento
        • Valley Clinical Trials, Inc.
        • Contacto:
      • Oxnard, California, Estados Unidos, 93030
        • Aún no reclutando
        • Fomat Medical Research
        • Contacto:
      • Spring Valley, California, Estados Unidos, 91978
        • Reclutamiento
        • Encompass Clinical Research, Spring Valley
        • Contacto:
      • Tustin, California, Estados Unidos, 92780
        • Aún no reclutando
        • University Clinical Investigators, Inc.
        • Contacto:
      • Walnut Creek, California, Estados Unidos, 94598
        • Reclutamiento
        • Diablo Clinical Research
        • Contacto:
      • West Hills, California, Estados Unidos, 91307
        • Reclutamiento
        • Focus Clinical Research
        • Contacto:
    • Florida
      • Clearwater, Florida, Estados Unidos, 33765
        • Reclutamiento
        • Clinical Research of West Florida, Inc.
        • Contacto:
      • Fleming Island, Florida, Estados Unidos, 32003
        • Aún no reclutando
        • Northeast Research Institute
        • Contacto:
      • Fort Myers, Florida, Estados Unidos, 33912
        • Reclutamiento
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Contacto:
      • Hollywood, Florida, Estados Unidos, 33024
        • Reclutamiento
        • Encore Medical Research
        • Contacto:
      • Jacksonville, Florida, Estados Unidos, 32204
        • Aún no reclutando
        • Northeast Research Institute
        • Contacto:
      • Lakeland, Florida, Estados Unidos, 33803
        • Aún no reclutando
        • Accel Research Sites - Lakeland
        • Contacto:
      • Lakeland, Florida, Estados Unidos, 33805
        • Aún no reclutando
        • Clinical Research of Central Florida - Lakeland
        • Contacto:
      • Largo, Florida, Estados Unidos, 33777
        • Reclutamiento
        • Tampa Bay Medical Research - Largo
        • Contacto:
      • Miami, Florida, Estados Unidos, 33165
        • Aún no reclutando
        • New Horizon Research Center-Miami-69732
        • Contacto:
      • Miramar, Florida, Estados Unidos, 33027
        • Aún no reclutando
        • South Broward Research
        • Contacto:
      • Riverview, Florida, Estados Unidos, 33578
        • Reclutamiento
        • Covenant Metabolic Specialists, LLC - Brandon
        • Contacto:
      • University Park, Florida, Estados Unidos, 34201
        • Reclutamiento
        • Covenant Metabolic Specialists, LLC - Sarasota
        • Contacto:
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Aún no reclutando
        • Metabolic Research Institute, Inc.
        • Contacto:
      • Weston, Florida, Estados Unidos, 33331
        • Reclutamiento
        • Encore Medical Research - Weston
        • Contacto:
      • Winter Park, Florida, Estados Unidos, 32789
    • Georgia
      • Columbus, Georgia, Estados Unidos, 31904
        • Reclutamiento
        • Centricity Research, Endocrine Consultants
        • Contacto:
      • Fayetteville, Georgia, Estados Unidos, 30214
        • Reclutamiento
        • Javara-Fayetteville-67354
        • Contacto:
      • Lawrenceville, Georgia, Estados Unidos, 30046
        • Aún no reclutando
        • Balanced Life Health Care Solutions
        • Contacto:
      • Union City, Georgia, Estados Unidos, 30291
        • Aún no reclutando
        • Rophe Adult and Pediatric Medicine
        • Contacto:
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Aún no reclutando
        • Pacific Diabetes & Endocrine Center
        • Contacto:
    • Idaho
      • Blackfoot, Idaho, Estados Unidos, 83221
        • Aún no reclutando
        • Elite Clinical Trials - Blackfoot
        • Contacto:
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Aún no reclutando
        • Family First Clinical Research
        • Contacto:
      • Meridian, Idaho, Estados Unidos, 83646
        • Aún no reclutando
        • Solaris Clinical Research
        • Contacto:
    • Illinois
      • Skokie, Illinois, Estados Unidos, 60077
        • Aún no reclutando
        • Evanston Premier Healthcare Research LLC
        • Contacto:
    • Kansas
      • Topeka, Kansas, Estados Unidos, 66606
        • Aún no reclutando
        • Cotton O'Neil Mulvane
        • Contacto:
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
    • Maryland
      • Rockville, Maryland, Estados Unidos, 20852
        • Aún no reclutando
        • Endocrine and Metabolic Consultants
        • Contacto:
    • Michigan
      • Buckley, Michigan, Estados Unidos, 49620
        • Aún no reclutando
        • Northern Pines Health Center - Buckley
        • Contacto:
      • Dearborn, Michigan, Estados Unidos, 48126
        • Reclutamiento
        • Revival Research Institute, LLC - Dearborn
        • Contacto:
      • Troy, Michigan, Estados Unidos, 48098
        • Aún no reclutando
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Contacto:
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55416
        • Aún no reclutando
        • International Diabetes Center
        • Contacto:
    • Mississippi
      • Olive Branch, Mississippi, Estados Unidos, 38654
        • Aún no reclutando
        • Olive Branch Family Medical Center
        • Contacto:
      • Ridgeland, Mississippi, Estados Unidos, 39157
        • Aún no reclutando
        • SKY Clinical Research Network Group - Ridgeland
        • Contacto:
    • Missouri
      • City of Saint Peters, Missouri, Estados Unidos, 63303
        • Aún no reclutando
        • StudyMetrix Research, LLC
        • Contacto:
    • Montana
      • Kalispell, Montana, Estados Unidos, 59901
        • Aún no reclutando
        • Logan Health Research - Kalispell
        • Contacto:
      • Missoula, Montana, Estados Unidos, 59804
        • Aún no reclutando
        • Boeson Research - Missoula
        • Contacto:
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Aún no reclutando
        • Palm Research Center
        • Contacto:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87102
        • Aún no reclutando
        • Albuquerque Clinical Trials
        • Contacto:
    • New York
      • Brooklyn, New York, Estados Unidos, 11215
        • Aún no reclutando
        • Ellipsis Research Group - Brooklyn
        • Contacto:
    • North Carolina
      • Fayetteville, North Carolina, Estados Unidos, 28304
        • Aún no reclutando
        • Javara Inc. - Cape Fear Valley Medical Center
        • Contacto:
      • Greensboro, North Carolina, Estados Unidos, 27408
        • Aún no reclutando
        • PharmQuest Life Sciences
        • Contacto:
      • Morehead City, North Carolina, Estados Unidos, 28557
        • Reclutamiento
        • Centricity Research - Morehead City
        • Contacto:
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Aún no reclutando
        • Diabetes & Endocrinology Associates of Stark County
        • Contacto:
      • Maumee, Ohio, Estados Unidos, 43537
        • Aún no reclutando
        • Advanced Medical Research - Maumee
        • Contacto:
      • Wadsworth, Ohio, Estados Unidos, 44281
        • Aún no reclutando
        • New Venture Medical Research
        • Contacto:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73134
        • Reclutamiento
        • Tekton Research Oklahoma City
        • Contacto:
    • Pennsylvania
      • Beaver, Pennsylvania, Estados Unidos, 15009
        • Aún no reclutando
        • Heritage Valley Medical Group
        • Contacto:
      • Pittsburgh, Pennsylvania, Estados Unidos, 15236
        • Aún no reclutando
        • Preferred Primary Care Physicians-Pittsburgh-63932
        • Contacto:
      • Pittsburgh, Pennsylvania, Estados Unidos, 15243
        • Aún no reclutando
        • Preferred Primary Care Physicians
        • Contacto:
      • Uniontown, Pennsylvania, Estados Unidos, 15401
        • Aún no reclutando
        • Preferred Primary Care Physicians - Matthew Drive
        • Contacto:
    • South Carolina
      • Bluffton, South Carolina, Estados Unidos, 29910
        • Aún no reclutando
        • PanAmerican Clinical Research - Bluffton
        • Contacto:
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Aún no reclutando
        • Spartanburg Medical Research
        • Contacto:
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37411
        • Reclutamiento
        • University Diabetes & Endocrine Consultants
        • Contacto:
      • Memphis, Tennessee, Estados Unidos, 38115
        • Aún no reclutando
        • LifeDoc Research, PLLC
        • Contacto:
    • Texas
      • Austin, Texas, Estados Unidos, 78731
        • Reclutamiento
        • Texas Diabetes and Endocrinology - Central Austin
        • Contacto:
      • Brownsville, Texas, Estados Unidos, 78520
        • Aún no reclutando
        • South Texas Research Institute - Brownsville
        • Contacto:
      • Conroe, Texas, Estados Unidos, 77384
        • Reclutamiento
        • Privia Medical Group Gulf Coast, PLLC
        • Contacto:
      • Dallas, Texas, Estados Unidos, 75390-8837
        • Aún no reclutando
        • University of Texas Southwestern Medical Center
        • Contacto:
      • Georgetown, Texas, Estados Unidos, 78626
        • Reclutamiento
        • Pinnacle Clinical Research - Georgetown
        • Contacto:
      • Houston, Texas, Estados Unidos, 77040
        • Aún no reclutando
        • Juno Research, LLC
        • Contacto:
      • Houston, Texas, Estados Unidos, 77084
        • Aún no reclutando
        • Biopharma Informatic, Inc. Research Center
        • Contacto:
      • Houston, Texas, Estados Unidos, 77089
        • Aún no reclutando
        • Research Physicians Network
        • Contacto:
      • Mesquite, Texas, Estados Unidos, 75149
        • Aún no reclutando
        • Southern Endocrinology Associates
        • Contacto:
      • San Antonio, Texas, Estados Unidos, 78229
        • Aún no reclutando
        • Pinnacle Clinical Research, LLC
        • Contacto:
      • San Antonio, Texas, Estados Unidos, 78222
        • Reclutamiento
        • Pinnacle Clinical Research - San Antonio
        • Contacto:
      • Shavano Park, Texas, Estados Unidos, 78231
        • Aún no reclutando
        • Consano Clinical Research
        • Contacto:
      • Weslaco, Texas, Estados Unidos, 78596
        • Aún no reclutando
        • Texas Valley Clinical Research
        • Contacto:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84117
        • Reclutamiento
        • Olympus Family Medicine
        • Contacto:
    • Virginia
      • Newport News, Virginia, Estados Unidos, 23606
        • Aún no reclutando
        • Tidewater Physicians Multispecialty Group
        • Contacto:
    • Washington
      • Redmond, Washington, Estados Unidos, 98052
        • Reclutamiento
        • ERA Health Research - Redmond
        • Contacto:
    • Wisconsin
      • Kenosha, Wisconsin, Estados Unidos, 53144
        • Aún no reclutando
        • Clinical Investigation Specialists, Inc.-Kenosha-69111
        • Contacto:
  • India
      • Ahmedabad, India, 380006
        • Aún no reclutando
        • Gujarat Endocrine Centre
        • Contacto:
      • Ahmedabad, India, 380006
        • Aún no reclutando
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Contacto:
      • Bhubaneswar, India, 751019
        • Aún no reclutando
        • AIIMS Bhubaneshwar
        • Contacto:
      • Cuttack, India, 753007
        • Aún no reclutando
        • S.C.B. Medical College & Hospital
        • Contacto:
      • Hyderabad, Afzalgunj, India, 500012
        • Aún no reclutando
        • Osmania Medical College & Hospital
        • Contacto:
      • Kolhāpur, India, 416003
        • Aún no reclutando
        • Shree Mahalaxmi Diatone Institute
        • Contacto:
      • Lucknow, India, 226 014
        • Aún no reclutando
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contacto:
      • Nagpur, India, 440010
        • Aún no reclutando
        • Diabetes Care and Research Centre
        • Contacto:
      • Nashik, India, 422002
        • Aún no reclutando
        • Supe Heart & Diabetes Hospital & Research Centre
        • Contacto:
      • New Delhi, India, 110029
        • Aún no reclutando
        • AIIMS, New Delhi
        • Contacto:
      • Pune, India, 411004
        • Aún no reclutando
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contacto:
      • Trivandrum, India, 695032
        • Aún no reclutando
        • Jothydev's Diabetes Research Centre
        • Contacto:
      • Visakhapatnam, India, 530040
        • Aún no reclutando
        • Vishakha Institute of Medical Sciences
        • Contacto:
  • Nueva Zelanda
      • Auckland, Nueva Zelanda, 0626
        • Aún no reclutando
        • Waitemata Clinical Research
        • Contacto:
      • Hamilton, Nueva Zelanda, 3204
        • Aún no reclutando
        • Clinical Trials New Zealand Ltd
        • Contacto:
    • Christchurch
      • Christchurch Central City, Christchurch, Nueva Zelanda, 8011
        • Aún no reclutando
        • New Zealand Clinical Research (NZCR) Christchurch
        • Contacto:
    • Dunedin
      • Central Dunedin, Dunedin, Nueva Zelanda, 9016
        • Aún no reclutando
        • Momentum Clinical Research Dunedin
        • Contacto:
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Aún no reclutando
        • Isis Clinical Research Center
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Part A: Placebo
Placebo as an add-on to diet and exercise.
Droga: Placebo
Placebo
Experimental: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906
Experimental: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906
Comparador de placebos: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Droga: Placebo
Placebo
Experimental: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906
Experimental: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906
Comparador de placebos: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Placebo
Placebo
Experimental: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906
Experimental: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Droga: Sobrevuditud
Sobrevuditud
Otros nombres:
  • BI 456906

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Periodo de tiempo: At baseline and Week 41.
At baseline and Week 41.

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de agosto de 2026

Finalización primaria (Estimado)

17 de enero de 2028

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2026

Publicado por primera vez (Actual)

10 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1404-0115

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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