Current partner codePEPTIDESDE
NCT06066515·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

726

Locations

118

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

survodutide

once weekly subcutaneous injection

COMBINATION_PRODUCT

Placebo

once weekly subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Oct 4, 2023

  2. Study start

    Nov 25, 2023

  3. Primary completion

    Dec 2, 2025

  4. Study completion

    Feb 20, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 12, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage change in body weight from baseline to Week 76

Time frame · Baseline and at Week 76

Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

Time frame · Baseline and at Week 76

Secondary outcomes

Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76

Time frame · Baseline and at Week 76

Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76

Time frame · Baseline and at Week 76

Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76

Time frame · Baseline and at Week 76

Absolute change from baseline to Week 76 in body weight (kg)

Time frame · Baseline and Week 76

Absolute change from baseline to Week 76 in waist circumference (cm)

Time frame · Baseline and at Week 76

Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)

Time frame · Baseline and at Week 76

Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)

Time frame · Baseline and at Week 76

"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.

Absolute change from baseline to Week 76 in Eating Behaviour PRO total score

Time frame · Baseline and at Week 76

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).

Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)

Time frame · Baseline and at Week 76

Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)

Time frame · Baseline and at Week 76

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

118 registered sites.

Australia · Belgium · Canada · China · Finland · Germany · Japan · Netherlands · New Zealand · Poland · South Korea · Sweden · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

EmVenio Research-Phoenix-69743

Phoenix, Arizona, United States

Encompass Clinical Research, Spring Valley

Spring Valley, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Alliance for Multispecialty Research, LLC - Doral

Doral, Florida, United States

University of Florida

Gainesville, Florida, United States

East Coast Institute for Research, LLC - Jacksonville

Jacksonville, Florida, United States

New Horizon Research Center-Miami-69732

Miami, Florida, United States

West Orange Endocrinology

Ocoee, Florida, United States

East-West Medical Research

Honolulu, Hawaii, United States

Solaris Clinical Research

Meridian, Idaho, United States

Evanston Premier Healthcare Research LLC

Skokie, Illinois, United States

Velocity Clinical Research-Valparaiso-68883

Valparaiso, Indiana, United States

Velocity Clinical Research-Sioux City-69728

Sioux City, Iowa, United States

AMR Lexington

Lexington, Kentucky, United States

L-MARC Research Center

Louisville, Kentucky, United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri, United States

Premier Research, Inc.

Trenton, New Jersey, United States

Velocity Clinical Research - Binghamton

Binghamton, New York, United States

Southgate Medical Group/ Southgate Medical Park

West Seneca, New York, United States

Physicians East, PA

Greenville, North Carolina, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

Accellacare-Wilmington-67123

Wilmington, North Carolina, United States

Valley Weight Loss Clinic

Fargo, North Dakota, United States

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.