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

2026년 10월 28일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

600

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Part A: Placebo

Placebo as an add-on to diet and exercise.
의약품: Placebo

Placebo
실험적: Part A: Low-dose survodutide

Low-dose survodutide as an add-on to diet and exercise.
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906
실험적: Part A: High-dose survodutide

High-dose survodutide as add-on to diet and exercise
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906
위약 비교기: Part B: Placebo

Placebo as an add-on to anti-diabetic drugs.
의약품: Placebo

Placebo
실험적: Part B: Low-dose survodutide

Low-dose survodutide as an add-on to anti-diabetic drugs.
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906
실험적: Part B: High-dose survodutide

High-dose survodutide as an add-on to anti-diabetic drugs.
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906
위약 비교기: Part C: Placebo

Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
의약품: Placebo

Placebo
실험적: Part C: Low-dose survodutide

Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906
실험적: Part C: High-dose survodutide

High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
의약품: Survodutide

Survodutide

다른 이름들:
  • BI 456906

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
기간: At baseline and Week 41.
At baseline and Week 41.

2차 결과 측정

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

CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
At baseline and Week 53.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 24일

기본 완료 (추정된)

2028년 1월 17일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2026년 8월 5일

QC 기준을 충족하는 최초 제출

2026년 8월 5일

처음 게시됨 (실제)

2026년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 28일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1404-0115

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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