Clinical trial NCT06066528: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Official title: A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.

The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.

Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.

The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.


Eligibility criteria: 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. Body mass index (BMI) ≥27 kg/m\^2 at screening.
3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening.
4. HbA1c ≥6.5% (≥48 mmol/mol) and \<10% (\<86 mmol/mol) as measured by the central laboratory at screening.
5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.

Exclusion Criteria:

1. Body weight change (self-reported) of \>5% within 3 months before screening.
2. Treatment with any medication for the indication obesity within 3 months before screening.
3. Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor \[DPP-4il).
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
5. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase \>2x upper limit of normal (ULN)) as measured by the central laboratory at screening.
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Further exclusion criteria apply.

Primary outcomes:
measure: Percentage change in body weight from baseline to Week 76
timeFrame: Baseline and at Week 76
measure: Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
timeFrame: Baseline and at Week 76
Secondary outcomes:
measure: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
timeFrame: Baseline and at Week 76
measure: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
timeFrame: Baseline and at Week 76
measure: Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in body weight (kg)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in waist circumference (cm)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
timeFrame: Baseline and at Week 76
measure: Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in triglycerides (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
timeFrame: Baseline and at Week 76
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Phoenix
country: United States
facility: EmVenio Research-Atlanta-69582
state: Arizona
city: Spring Valley
country: United States
facility: Encompass Clinical Research, Spring Valley
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research-Coral Gables-68872
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC-Jacksonville-55146
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center-Miami-69732
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Skokie
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research-Valparaiso-68883
state: Indiana
city: Sioux City
country: United States
facility: Velocity Clinical Research-Sioux City-69728
state: Iowa
city: Lexington
country: United States
facility: AMR Lexington
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC
state: Missouri
city: Atlantic City
country: United States
facility: Walgreens Clinical Trials-Atlantic City-69647
state: New Jersey
city: Perth Amboy
country: United States
facility: Walgreens Clinical Trials-Perth Amboy-69648
state: New Jersey
city: Trenton
country: United States
facility: Premier Research, Inc.
state: New Jersey
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group/ Southgate Medical Park
state: New York
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare-Wilmington-67123
state: North Carolina
city: Oklahoma City
country: United States
facility: EmVenio Research-Oklahoma City-70053
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Merewether
country: Australia
facility: Hunter Diabetes Centre
state: New South Wales
city: Milton
country: Australia
facility: CORE Research Group
state: Queensland
city: Southport
country: Australia
facility: Griffith Health
state: Queensland
city: Box Hill
country: Australia
facility: Monash University
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research
state: Western Australia
city: Aalst
country: Belgium
facility: ASZ - Campus Aalst
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: Roeselare - HOSP AZ Delta
city: Calgary
country: Canada
facility: Centricity Research (Calgary)
state: Alberta
city: Vancouver
country: Canada
facility: Dr. James Lai
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd.
state: Ontario
city: Hamilton
country: Canada
facility: The Wharton Medical Clinic Clinical Trials Inc.
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: Oshawa
country: Canada
facility: James Cha, MD
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Albion Finch Medical Centre
state: Ontario
city: Waterloo
country: Canada
facility: Sameh Fikry Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montreal
country: Canada
facility: Power Clinical Research
state: Quebec
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Harbin
country: China
facility: Forth Clinical Hospital of Harbin Medical University
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Jinan
country: China
facility: Center Hospital of Jinan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital affiliated to Fudan University
city: Siping
country: China
facility: Siping Central People's Hospital
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Nachod
country: Czechia
facility: EDUMED s.r.o.
city: Olomouc
country: Czechia
facility: NZZ Agentura Science Pro s.r.o., Olomouc
city: Pilsen
country: Czechia
facility: Dieko, s.r.o.
city: Prague
country: Czechia
facility: Polyclinic Michnova Ltd.
city: Prague
country: Czechia
facility: Private Practice - Dr. Barbora Diepoltova
city: Gandrup
country: Denmark
facility: Sanos Clinic Gandrup (SMO)
city: Helsinki
country: Finland
facility: HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
city: Kuopio
country: Finland
facility: Itä-Suomen yliopisto/Health Step Finland Oy
city: Turku
country: Finland
facility: CRST - Clinical Research Services Turku
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Fulda
country: Germany
facility: MVZ im Altstadt-Caree Fulda GmbH
city: Hamburg
country: Germany
facility: Diabetes Zentrum Hamburg West
city: Münster
country: Germany
facility: Institut für Diabetesforschung Münster GmbH
city: Oldenburg
country: Germany
facility: RED Institut GmbH
city: Witten
country: Germany
facility: Forschungszentrum Ruhr, KliFo Center GmbH
city: Athens
country: Greece
facility: Athens Medical Center
city: Thermi
country: Greece
facility: Thermi Clinic
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Balatonfured
country: Hungary
facility: DRC Drug Research Ltd-Balatonfured-59734
city: Debrecen
country: Hungary
facility: Belinus Bt
city: Kistarcsa
country: Hungary
facility: CRU Hungary Ltd.
city: Oroshaza
country: Hungary
facility: Arina Trial Research kft.
city: Szeged
country: Hungary
facility: University of Szeged
city: Fukuoka, Fukuoka
country: Japan
facility: Fukuhama Chuo Clinic
city: Ibaraki, Koga
country: Japan
facility: Itabashi Diabetic medicine and Dermatology Clinic
city: Ibaraki, Ushiku
country: Japan
facility: Noritake Clinic
city: Saitama, Soka
country: Japan
facility: Soka Sugiura Naika Clinic
city: Tochigi, Oyama
country: Japan
facility: Oyama East Clinic
city: Tokyo, Hachioji
country: Japan
facility: Hachioji Diabetes Clinic
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ. Hosp
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St.Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Born
country: Netherlands
facility: PT & R
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Dunedin
country: New Zealand
facility: P3 Research Dunedin
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Tasman
city: Newtown Wellington NZ
country: New Zealand
facility: P3 Research-Newtown Wellington NZ-33770
city: Rosedale, Auckland
country: New Zealand
facility: Optimal Clinical Trials North
city: Tauranga
country: New Zealand
facility: P3 Research-Tauranga-34833
city: Gdansk
country: Poland
facility: PI HOUSE Sp. z o.o., Gdansk
city: Lublin
country: Poland
facility: ETG Lublin
city: Pulawy
country: Poland
facility: Velocity Nova Sp z o.o.
city: Siedlce
country: Poland
facility: ETG Siedlce
city: Tarnow
country: Poland
facility: Clinical Research Center METABOLICA lek. Robert Witek
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Vithas Sevilla
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova-Lleida-17625
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital de Canarias
city: Borås
country: Sweden
facility: Ladulaas Kliniska Studier
city: Göteborg
country: Sweden
facility: Forskningsenheten Carlanderska
city: Malmö
country: Sweden
facility: Pharmasite Malmo
city: Stockhom
country: Sweden
facility: Sabbatsbergs sjukhus
city: Örebro
country: Sweden
facility: Medicinmottagning 5/Överviktsenheten
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Bradford on Avon
country: United Kingdom
facility: Bradford on Avon Health Centre
city: Hayle
country: United Kingdom
facility: Mounts Bay Medical Limited
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre, Rotherham
city: Trowbridge
country: United Kingdom
facility: Trowbridge Health Centre
Study officials:
References: