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New injection aims to shed pounds: phase 2 trial launches

NCT ID NCT07662122

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 14 times

Summary

This study tests an experimental drug called BI 3034701 to help people with obesity or overweight lose weight. About 300 adults aged 18-74 will receive either the drug or a placebo injection for 42 weeks, along with diet and exercise advice. Researchers will measure weight changes and check for side effects.

What this could mean

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

Active substance
BI 3034701
What this could lead to
If successful, this could lead to a new weight-loss medication for people with obesity or overweight who struggle to lose weight through diet alone.
What could go wrong
This is an early Phase 2 trial, so the drug may not prove effective or safe enough to advance. Weight loss results can vary, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

342 people

The number who actually took part.

Started

Jun 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

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 to 74 years

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 to \<75 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/m² at screening, OR BMI ≥27 kg/m² at screening with the presence of at least 1 weight-related complication. 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently 5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information sheet and in protocol. 6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Sign the informed consent form (ICF); Learn how to self-inject the investigational medicinal product (IMP)(s) in the abdomen as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP(s)) OR Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and physical activity plan), maintain diaries, complete required questionnaires, and handle the IMP(s) as described in the instructions for use (IFU) Exclusion criteria: 1. Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening 2. Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months before screening 3. Prior surgery of the gastrointestinal (GI) tract that could interfere with body weight including minimally invasive/endoscopic bariatric devices and any bariatric or metabolic surgery involving resection, sleeve gastrectomy, or bypass procedures (e.g. Roux-en-Y, one-anastomosis gastric bypass, duodenal-jejunal bypass sleeve), regardless of whether the device or bypass was removed. The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening 4. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) 5. A Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening 6. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose-lowering agent starting within 3 months before screening 7. Use of glucagon-like-peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR) or neuropeptide Y receptor 2 (NPY2R) agonists (or the combinations thereof) within 3 months before screening 8. Answered "yes" to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening visit up to and including the randomisation visit Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Obesity Overweight

Contacts and locations

Locations

  • Accellacare-Wilmington-67123

    Wilmington, North Carolina, 28401, United States

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226, United States

  • Apex Trials (Guelph)

    Guelph, Ontario, N1G 0B4, Canada

  • Arcturus Healthcare - Troy Internal Medicine Research Division

    Troy, Michigan, 48098, United States

  • Banbury Cross Health Centre

    Oxford, OX16 9AD, United Kingdom

  • Cahaba Research, Inc. - Trussville Location

    Birmingham, Alabama, 35235, United States

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2, Canada

  • Center Hospital of Jinan

    Jinan, 250013, China

  • Centre Medical Acadie (9109-0126 Quebec Inc)

    Montreal, Quebec, H4N 2W2, Canada

  • Centricity Research - Morehead City

    Morehead City, North Carolina, 28557, United States

  • Clinvest Research LLC

    Springfield, Missouri, 65807, United States

  • Coastal Digestive Health & CDH Research Institute

    Maroochydore, Queensland, 4558, Australia

  • Data Point Clinical, LLC

    Kirkland, Washington, 98034, United States

  • Diex Recherche (Quebec)

    Québec, G1V 4T3, Canada

  • Diex Recherche (Sherbrooke Est)

    Sherbrooke, Quebec, J1E 0N8, Canada

  • Diex Recherche (Victoriaville)

    Victoriaville, Quebec, G6P 3Z8, Canada

  • Dr. M. B. Jones Inc.

    Victoria, British Columbia, V8V 4A1, Canada

  • Eastern Health-Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9, Canada

  • First Hospital of Qinhuangdao

    Qinhuangdao, 066099, China

  • Focus Clinical Research

    West Hills, California, 91307, United States

  • Fylde Coast Clinical Research

    Blackpool, FY3 7EN, United Kingdom

  • Hilltop Medical Clinic

    Surrey, British Columbia, V4A 0C1, Canada

  • Huzhou Central Hospital

    Huzhou, 313000, China

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • Javara-Fayetteville-67354

    Fayetteville, Georgia, 30214, United States

  • Leicester General Hospital

    Leicester, LE5 4PW, United Kingdom

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104, United States

  • Linthorpe Surgery

    Middlesbrough, TS5 6HA, United Kingdom

  • Milestone Research Inc.

    London, Ontario, N5W 6A2, Canada

  • Momentum Clinical Research Dunedin

    Central Dunedin, Dunedin, 9016, New Zealand

  • Momentum Clinical Research Wellington

    Mount Cook, Wellington Region, 6021, New Zealand

  • Monroe Biomedical Research - Louisville

    Louisville, Kentucky, 40213, United States

  • Ocean West Research Clinic (Surrey)

    Surrey, British Columbia, V3Z 2N6, Canada

  • Optimus U Corporation-Miami-69452

    Miami, Florida, 33135, United States

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • South Texas Research Institute - Brownsville

    Brownsville, Texas, 78520, United States

  • South Texas Research Institute-Edinburg-67012

    Edinburg, Texas, 78539, United States

  • Southern Adelaide Diabetes and Endocrine Services (SADES)

    Oaklands Park, South Australia, 5046, Australia

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2, Canada

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303, United States

  • THEO Medical (Montreal)

    Montreal, Quebec, H3M 1L3, Canada

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731, United States

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

    Luoyang, 471000, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010, China

  • The Garth Surgery

    Guisborough, TS14 7DJ, United Kingdom

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011, China

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario, L8L 5G8, Canada

  • Tianjin Medical University Chu Hisen-I Memorial Hospital

    Tianjin, 300070, China

  • Tribe Clinical Research at Parkside OB-GYN, Greer

    Greer, South Carolina, 29650, United States

  • Velocity Clinical Research, High Wycombe

    High Wycombe, HP11 2QW, United Kingdom

  • Waitemata Clinical Research

    Auckland, 0626, New Zealand

  • Winterberry Research Inc.

    Hamilton, Ontario, L8J 0B6, Canada

  • Yichang Central People's Hospital

    Yichang, 443008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.