Clinical trial NCT06066515: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not 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 Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 727
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 (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² or more and at least one health problem related to their weight.

People with type 2 diabetes cannot take part in this study. 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 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 participants' body weight is regularly measured. 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) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:

   * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
   * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol 50 mg/dL (\<1.3 mmol/L) for women)
   * Obstructive sleep apnoea
   * Others.
3. 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. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
7. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase \>2x upper limit of normal (ULN) as measured by the central laboratory at screening.
8. 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 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 the Eating Behaviour patient reported outcome (PRO)
timeFrame: Baseline and at Week 76
measure: 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 diastolic blood pressure (DBP) (mmHg)
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 HbA1c (mmol/mol)
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
measure: Absolute change from baseline to Week 76 in total fat volume (L)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in lean body volume (L)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in visceral fat volume (L)
timeFrame: Baseline and at Week 76
measure: Absolute change from baseline to Week 76 in subcutaneous fat volume (L)
timeFrame: Baseline and at Week 76.
measure: Relative change from baseline to Week 76 in total fat volume (%)
timeFrame: Baseline and at Week 76
measure: Relative change from baseline to Week 76 in lean body volume (%)
timeFrame: Baseline and at Week 76
measure: Relative change from baseline to Week 76 in visceral fat volume (%)
timeFrame: Baseline and at Week 76
measure: Relative change from baseline to Week 76 in subcutaneous fat volume (%)
timeFrame: Baseline and at Week 76.
measure: Relative change from baseline to Week 76 in liver fat content (%)
timeFrame: Baseline and at Week 76
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: EmVenio Research-Phoenix-69743
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: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
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: 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: 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: Fargo
country: United States
facility: Valley Weight Loss Clinic
state: North Dakota
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: 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: Edegem
country: Belgium
facility: Edegem - UNIV UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: Roeselare - HOSP AZ Delta
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: Greenfield Park
country: Canada
facility: ViaCar Recherches Cliniques Inc. (Greenfield Park)
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: 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: Helsinki
country: Finland
facility: HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
city: Jyväskylä
country: Finland
facility: StudyCor Oy
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: Fukuoka, Fukuoka
country: Japan
facility: Fukuhama Chuo Clinic
city: Hyogo, Kobe
country: Japan
facility: Kobe University Hospital
city: Ibaraki, Ushiku
country: Japan
facility: Noritake Clinic
city: Saitama, Soka
country: Japan
facility: Soka Sugiura Naika 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: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung 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: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
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: Borås
country: Sweden
facility: Ladulaas Kliniska Studier
city: Göteborg
country: Sweden
facility: Forskningsenheten Carlanderska
city: Stockholm
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: Burbage, Hinkley
country: United Kingdom
facility: Burbage Surgery
city: Nantwich
country: United Kingdom
facility: Kiltearn Medical Centre
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre, Rotherham
city: Trowbridge
country: United Kingdom
facility: Trowbridge Health Centre
Study officials:
References: