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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID: NCT06066515
Run by: Boehringer Ingelheim
People needed: 726
Starts: 2023-11-25
Expected to finish: 2026-02-20
Last updated by the study team: 2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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.
History of at least one self-reported unsuccessful dietary effort to lose body weight.
Further inclusion criteria apply.

You may not qualify if…

Body weight change (self-reported) of >5% within 3 months before screening.
Treatment with any medication for the indication obesity within 3 months before screening.
Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
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.
Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
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.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Further exclusion criteria apply.

Where it is running

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
EmVenio Research-Oklahoma City-70053 — Oklahoma City, Oklahoma, United States
EmVenio Research-Phoenix-69743 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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