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New weekly shot shows promise for major weight loss in obesity trial

NCT ID NCT06066515

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called survodutide (BI 456906) to help people with obesity or overweight lose weight. Over 700 adults without type 2 diabetes received either the drug or a placebo injection once a week for about a year and a half, along with diet and exercise advice. Researchers measured weight changes and checked for side effects to see if the treatment is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
survodutide (BI 456906), a once-weekly injection
What this could lead to
If it works, this could provide a new treatment option for significant weight loss in people with obesity or overweight.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Weight loss may vary, and side effects like nausea or injection site reactions are possible. Long-term safety and effectiveness are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

726 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • ASZ - Campus Aalst

    Aalst, 9300, Belgium

  • Accellacare-Wilmington-67123

    Wilmington, North Carolina, 28401, United States

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013, China

  • Aggarwal and Associates Ltd.

    Brampton, Ontario, L6T 0G1, Canada

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4, Canada

  • Alliance for Multispecialty Research, LLC - Doral

    Doral, Florida, 33172, United States

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004, Australia

  • Beijing Pinggu Hospital

    Beijing, 101200, China

  • Bradford on Avon Health Centre

    Bradford-on-Avon, BA15 1DQ, United Kingdom

  • Burbage Surgery

    Burbage, Hinkley, LE10 2SE, United Kingdom

  • CORE Research Group

    Milton, Queensland, 4064, Australia

  • CRST - Clinical Research Services Turku

    Turku, 20520, Finland

  • Center Hospital of Jinan

    Jinan, 250013, China

  • Changzhou Second People's Hospital

    Changzhou, 213004, China

  • Clifton Medical Centre, Rotherham

    Rotherham, S65 1DA, United Kingdom

  • Clinical Research Center METABOLICA lek. Robert Witek

    Tarnów, 33-100, Poland

  • Consano Clinical Research

    Shavano Park, Texas, 78231, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Diabetes Zentrum Hamburg West

    Hamburg, 22607, Germany

  • Diablo Clinical Research

    Walnut Creek, California, 94598, United States

  • Dongguk University Ilsan Hospital

    Goyang, 10326, South Korea

  • Dr. James Lai

    Vancouver, British Columbia, V5Z 4E1, Canada

  • ETG Lublin

    Lublin, 20-412, Poland

  • ETG Siedlce

    Siedlce, 08-110, Poland

  • East Coast Institute for Research, LLC - Jacksonville

    Jacksonville, Florida, 32216, United States

  • East-West Medical Research

    Honolulu, Hawaii, 96814, United States

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650, Belgium

  • EmVenio Research-Oklahoma City-70053

    Oklahoma City, Oklahoma, 73139, United States

  • EmVenio Research-Phoenix-69743

    Phoenix, Arizona, 85032, United States

  • Encompass Clinical Research, Spring Valley

    Spring Valley, California, 91978, United States

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077, United States

  • Forskningsenheten Carlanderska

    Gothenburg, 40545, Sweden

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599, China

  • Franciscus Gasthuis

    Rotterdam, 3045 PM, Netherlands

  • Fukuhama Chuo Clinic

    Fukuoka, Fukuoka, 810-0066, Japan

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Griffith Health

    Southport, Queensland, 4125, Australia

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

    Helsinki, 00290, Finland

  • Hachioji Diabetes Clinic

    Tokyo, Hachioji, 192-0083, Japan

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291, Australia

  • Huzhou Central Hospital

    Huzhou, 313000, China

  • InnoDiab Forschung GmbH

    Essen, 45136, Germany

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145, Germany

  • Itä-Suomen yliopisto/Health Step Finland Oy

    Kuopio, 70600, Finland

  • James Cha, MD

    Oshawa, Ontario, L1J 2K1, Canada

  • Juno Research, LLC

    Houston, Texas, 77040, United States

  • Kangbuk Samsung Hospital

    Seoul, 110-746, South Korea

  • Keogh Institute for Medical Research

    Nedlands, Western Australia, 6009, Australia

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX, United Kingdom

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017, Japan

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • L-MARC Research Center

    Louisville, Kentucky, 40213, United States

  • Ladulaas Kliniska Studier

    Borås, 506 30, Sweden

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557, United States

  • MVZ im Altstadt-Caree Fulda GmbH

    Fulda, 36037, Germany

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Medicinmottagning 5/Överviktsenheten

    Örebro, 70362, Sweden

  • Milestone Research Inc.

    London, Ontario, N5W 6A2, Canada

  • Monash University

    Box Hill, Victoria, 3128, Australia

  • New Horizon Research Center-Miami-69732

    Miami, Florida, 33165, United States

  • Noritake Clinic

    Ibaraki, Ushiku, 300-1207, Japan

  • Optimal Clinical Trials North

    Rosedale, Auckland, 0632, New Zealand

  • P3 Research Dunedin

    Dunedin, 9016, New Zealand

  • P3 Research-Newtown Wellington NZ-33770

    Newtown Wellington NZ, 6021, New Zealand

  • P3 Research-Tauranga-34833

    Tauranga, 3110, New Zealand

  • PI HOUSE Sp. z o.o., Gdansk

    Gdansk, 80-546, Poland

  • PT & R

    Born, 6121 XK, Netherlands

  • Peking University People's Hospital

    Beijing, 100044, China

  • Physicians East, PA

    Greenville, North Carolina, 27834, United States

  • Pingxiang People's Hospital

    Pingxiang, 337000, China

  • Power Clinical Research

    Montreal, Quebec, H3M 1L3, Canada

  • Premier Research, Inc.

    Trenton, New Jersey, 08611, United States

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800, Belgium

  • Sabbatsbergs sjukhus

    Stockholm, 113 61, Sweden

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4, Canada

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240, China

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, 200071, China

  • Siping Central People's Hospital

    Siping, 136000, China

  • Soka Sugiura Naika Clinic

    Saitama, Soka, 340-0034, Japan

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Southern Clinical Trials Tasman

    Nelson, 7011, New Zealand

  • Southgate Medical Group/ Southgate Medical Park

    West Seneca, New York, 14224, United States

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2, Canada

  • StudyCor Oy

    Jyväskylä, 40620, Finland

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303, United States

  • Suzhou Municipal Hospital

    Suzhou, 215002, China

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731, United States

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, 14647, South Korea

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    Seoul, 07345, South Korea

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000, China

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011, China

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 100029, China

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario, L8L 5G8, Canada

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572, United States

  • Trowbridge Health Centre

    Trowbridge, BA14 8LW, United Kingdom

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 EZ, Netherlands

  • University of Florida

    Gainesville, Florida, 32610, United States

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104, United States

  • Velocity Clinical Research - Binghamton

    Binghamton, New York, 13905, United States

  • Velocity Clinical Research-Sioux City-69728

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research-Valparaiso-68883

    Valparaiso, Indiana, 46383, United States

  • Velocity Nova Sp z o.o.

    Puławy, 24-100, Poland

  • ViaCar Recherches Cliniques Inc. (Greenfield Park)

    Greenfield Park, Quebec, J4V 2G8, Canada

  • Waterloo Medical Centre

    Blackpool, FY4 3AD, United Kingdom

  • West Orange Endocrinology

    Ocoee, Florida, 34761, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

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