A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

June 17, 2026 updated by: Boehringer Ingelheim

A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight

This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study.

The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. 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 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Queensland, Australia, 4558
        • Coastal Digestive Health & CDH Research Institute
        • Contact:
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
    • Victoria
      • Box Hill, Victoria, Australia, 3128
  • Canada
      • Québec, Canada, G1V 4T3
    • British Columbia
      • Surrey, British Columbia, Canada, V4A 0C1
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Ocean West Research Clinic (Surrey)
        • Contact:
      • Victoria, British Columbia, Canada, V8V 4A1
    • Ontario
      • Guelph, Ontario, Canada, N1G 0B4
      • Hamilton, Ontario, Canada, L8L 5G8
        • The Wharton Medical Clinic Clinical Trials Inc.
        • Contact:
      • Hamilton, Ontario, Canada, L8J 0B6
      • London, Ontario, Canada, N5W 6A2
      • Stouffville, Ontario, Canada, L4A 1H2
        • Stouffville Medical Research Institute Inc.
        • Contact:
      • Toronto, Ontario, Canada, M3J 0K2
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
      • Montreal, Quebec, Canada, H3M 1L3
      • Montreal, Quebec, Canada, H4N 2W2
        • Centre Medical Acadie (9109-0126 Quebec Inc)
        • Contact:
      • Sherbrooke, Quebec, Canada, J1E 0N8
      • Victoriaville, Quebec, Canada, G6P 3Z8
  • China
      • Huzhou, China, 313000
      • Jinan, China, 250013
      • Luoyang, China, 471000
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanjing, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Ningbo, China, 315010
        • The first affiliated hospital of Ningbo university
        • Contact:
      • Qinhuangdao, China, 066099
      • Tianjin, China, 300070
        • Tianjin Medical University Chu Hisen-I Memorial Hospital
        • Contact:
      • Yichang, China, 443008
        • Yichang Central People's Hospital
        • Contact:
  • New Zealand
      • Grafton / Auckland, New Zealand, 1023
      • Waikanae, New Zealand, 5036
    • Otago
      • Dunedin, Otago, New Zealand, 9016
  • South Korea
      • Bucheon-si, South Korea, 14647
        • The Catholic University of Korea, Bucheon St.Mary's Hospital
        • Contact:
      • Daejeon, South Korea, 35233
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 02841
  • United Kingdom
      • High Wycombe, United Kingdom, HP11 2QW
      • Leicester, United Kingdom, LE5 4PW
      • Middlesbrough, United Kingdom, TS5 6HA
      • Oxford, United Kingdom, OX16 9AD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
    • Florida
      • Miami, Florida, United States, 33135
    • Georgia
      • Fayetteville, Georgia, United States, 30214
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Contact:
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
      • Springfield, Missouri, United States, 65807
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • South Carolina
      • Greer, South Carolina, United States, 29650
    • Texas
      • Austin, Texas, United States, 78731
      • Brownsville, Texas, United States, 78520
      • Edinburg, Texas, United States, 78539
      • San Antonio, Texas, United States, 78229
    • Washington
      • Renton, Washington, United States, 98057
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo matching BI 3034701
Placebo matching BI 3034701
Experimental: BI 3034701 treatment group 1
Drug: BI 3034701
BI 3034701
Experimental: BI 3034701 treatment group 2
Drug: BI 3034701
BI 3034701
Experimental: BI 3034701 treatment group 3
Drug: BI 3034701
BI 3034701
Experimental: BI 3034701 treatment group 4
Drug: BI 3034701
BI 3034701
Experimental: BI 3034701 treatment group 5
Drug: BI 3034701
BI 3034701
Experimental: BI 3034701 treatment group 6
Drug: BI 3034701
BI 3034701

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in body weight from baseline at Week 42 [%]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement of weight loss of ≥5% of baseline weight at Week 42
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Achievement of weight loss of ≥10% of baseline weight at Week 42
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Achievement of weight loss of ≥15% of baseline weight at Week 42
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Achievement of weight loss of ≥20% of baseline weight at Week 42
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Absolute change from baseline at Week 42 in body weight [kg]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist circumference [cm]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist-to-height ratio (WHtR) [dimensionless ratio]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.
Absolute change from baseline at Week 42 in diastolic blood pressure (DBP) [mmHg]
Time Frame: Baseline and at Week 42.
Baseline and at Week 42.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 29, 2026

Primary Completion (Estimated)

August 4, 2027

Study Completion (Estimated)

August 18, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1507-0002
  • U1111-1335-5538 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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