A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Obesity Clinical Trial

— SYNCHRONIZE™-1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06066515
• Other study ID #: 1404-0038
• Secondary ID: U1111-1288-94002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 15, 2023
• Est. completion date: January 16, 2026

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 725
• Est. completion date: January 16, 2026
• Est. primary completion date: December 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) =160 mg/dL (=4.1 mmol/L), or triglycerides =150 mg/dL (=1.7 mmol/L), or high density lipoprotein (HDL) <40 mg/dL (<1.0 mmol/L) for men or HDL<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 screening.

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 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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• survodutide
once weekly subcutaneous injection
• Placebo
once weekly subcutaneous injection

Locations

Country	Name	City	State
Australia	Monash University	Box Hill	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Australia	CORE Research Group	Milton	Queensland
Australia	Keogh Institute for Medical Research	Nedlands	Western Australia
Australia	Griffith Health	Southport	Queensland
Belgium	ASZ - Campus Aalst	Aalst
Belgium	Edegem - UNIV UZ Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
Belgium	Roeselare - HOSP AZ Delta	Roeselare
Canada	Aggarwal and Associates Ltd.	Brampton	Ontario
Canada	ViaCar Recherche Clinique Inc	Brossard	Quebec
Canada	The Wharton Medical Clinic Clinical Trials Inc.	Hamilton	Ontario
Canada	Milestone Research Inc.	London	Ontario
Canada	Power Clinical Research	Montreal	Quebec
Canada	James Cha, MD	Oshawa	Ontario
Canada	Stouffville Medical Centre	Stouffville	Ontario
Canada	Albion Finch Medical Centre	Toronto	Ontario
Canada	Dr. James Lai	Vancouver	British Columbia
Canada	Sameh Fikry Medicine Professional Corporation	Waterloo	Ontario
China	Beijing Pinggu Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Changzhou Second People's Hospital	Changzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	The Second Affiliated Hospital of Nanjing Medical University	Hangzhou
China	Forth Clinical Hospital of Harbin Medical University	Harbin
China	2nd Hospital Affiliated to Zhengzhou University	Henan Province
China	Huzhou Central Hospital	Huzhou
China	Center Hospital of Jinan	Jinan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang
China	Pingxiang People's Hospital	Pingxiang
China	Shanghai Fifth People's Hospital affiliated to Fudan University	Shanghai
China	Shanghai Municipal Hospital of Traditional Chinese Medicine	Shanghai
China	Siping Central People's Hospital	Siping
China	Suzhou Municipal Hospital	Suzhou
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an
China	Affiliated Hospital of Jiangsu University	Zhenjiang
Finland	HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki	Helsinki
Finland	StudyCor Oy	Jyväskylä
Finland	Itä-Suomen yliopisto/Health Step Finland Oy	Kuopio
Finland	CRST - Clinical Research Services Turku	Turku
Germany	InnoDiab Forschung GmbH	Essen
Germany	MVZ im Altstadt-Caree Fulda GmbH	Fulda
Germany	Diabetes Zentrum Hamburg West	Hamburg
Germany	Institut für Diabetesforschung Münster GmbH	Münster
Japan	Fukuhama Chuo Clinic	Fukuoka, Fukuoka
Japan	Kobe University Hospital	Hyogo, Kobe
Japan	Noritake Clinic	Ibaraki, Ushiku
Japan	Soka Sugiura Naika Clinic	Saitama, Soka
Japan	Hachioji Diabetes Clinic	Tokyo, Hachioji
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Kyungpook National Univ. Hosp	Daegu
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St.Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Netherlands	PT & R	Born
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Franciscus Gasthuis	Rotterdam
New Zealand	P3 Research Dunedin	Dunedin
New Zealand	Southern Clinical Trials Tasman	Nelson
New Zealand	P3 Research	Newtown Wellington NZ
New Zealand	Optimal Clinical Trials North	Rosedale, Auckland
New Zealand	P3 Research	Tauranga
Poland	PI HOUSE Sp. z o.o., Gdansk	Gdansk
Poland	ETG Lublin	Lublin
Poland	Velocity Nova Sp z o.o.	Pulawy
Poland	ETG Siedlce	Siedlce
Poland	Clinical Research Center METABOLICA lek. Robert Witek	Tarnow
Sweden	Ladulaas Kliniska Studier	Borås
Sweden	Forskningsenheten Carlanderska	Göteborg
Sweden	Medicinmottagning 5/Överviktsenheten	Örebro
Sweden	Sabbatsbergs sjukhus	Stockhom
United Kingdom	Waterloo Medical Centre	Blackpool
United Kingdom	Bradford on Avon Health Centre	Bradford on Avon
United Kingdom	Burbage Surgery	Burbage, Hinkley
United Kingdom	Kiltearn Medical Centre	Nantwich
United Kingdom	Clifton Medical Centre, Rotherham	Rotherham
United Kingdom	Trowbridge Health Centre	Trowbridge
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	Alliance for Multispecialty Research	Coral Gables	Florida
United States	Valley Weight Loss Clinic	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	Physicians East, PA	Greenville	North Carolina
United States	East-West Medical Research	Honolulu	Hawaii
United States	Juno Research, LLC	Houston	Texas
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	AMR Lexington	Lexington	Kentucky
United States	L-MARC Research Center	Louisville	Kentucky
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Solaris Clinical Research	Meridian	Idaho
United States	New Horizon Research Center	Miami	Florida
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	Yale University School of Medicine	New Haven	Connecticut
United States	West Orange Endocrinology	Ocoee	Florida
United States	EmVenio Research	Oklahoma City	Oklahoma
United States	EmVenio Research	Phoenix	Arizona
United States	Rainier Clinical Research Center	Renton	Washington
United States	StudyMetrix Research, LLC	Saint Peters	Missouri
United States	Diabetes & Glandular Disease Clinic, P.A.	San Antonio	Texas
United States	Consano Clinical Research	Shavano Park	Texas
United States	Velocity Clinical Research	Sioux City	Iowa
United States	Evanston Premier Healthcare Research LLC	Skokie	Illinois
United States	Encompass Clinical Research, Spring Valley	Spring Valley	California
United States	Premier Research, Inc.	Trenton	New Jersey
United States	Velocity Clinical Research	Valparaiso	Indiana
United States	Velocity Clinical Research, Vestal	Vestal	New York
United States	Diablo Clinical Research	Walnut Creek	California
United States	Southgate Medical Group/ Southgate Medical Park	West Seneca	New York
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Finland,  Germany,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight from baseline to Week 76		Baseline and at Week 76
Primary	Achievement of body weight reduction =5% (yes/no) from baseline to Week 76		Baseline and at Week 76
Secondary	Achievement of body weight reduction =10% (yes/no) from baseline to Week 76		Baseline and at Week 76
Secondary	Achievement of body weight reduction =15% (yes/no) from baseline to Week 76		Baseline and at Week 76
Secondary	Achievement of body weight reduction =20% (yes/no) from baseline to Week 76		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in body weight (kg)		Baseline and Week 76
Secondary	Absolute change from baseline to Week 76 in waist circumference (cm)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)	"Capacity to Resist" domain score of the Eating Behaviour PRO is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.	Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in Eating Behaviour PRO total score	Eating Behaviour PRO total score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist).	Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in HbA1c (mmol/mol)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in total cholesterol (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in triglycerides (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in free fatty acids (mg/dL)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in total fat volume (%)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in total fat volume (L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in lean body volume (%)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in lean body volume (L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in visceral fat volume (%)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in visceral fat volume (L)		Baseline and at Week 76
Secondary	Absolute change from baseline to Week 76 in subcutaneous fat volume (%)		Baseline and at Week 76.
Secondary	Absolute change from baseline to Week 76 in subcutaneous fat volume (L)		Baseline and at Week 76.
Secondary	Relative change from baseline to Week 76 in liver fat content (%)		Baseline and at Week 76

External Links

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