A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
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
2 other identifiers
interventional
300
7 countries
64
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Jun 2026
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
June 23, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2027
August 6, 2026
August 1, 2026
1.1 years
April 30, 2026
August 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change in body weight from baseline at Week 42 [%]
Baseline and at Week 42.
Secondary Outcomes (9)
Achievement of weight loss of ≥5% of baseline weight at Week 42
Baseline and at Week 42.
Achievement of weight loss of ≥10% of baseline weight at Week 42
Baseline and at Week 42.
Achievement of weight loss of ≥15% of baseline weight at Week 42
Baseline and at Week 42.
Achievement of weight loss of ≥20% of baseline weight at Week 42
Baseline and at Week 42.
Absolute change from baseline at Week 42 in body weight [kg]
Baseline and at Week 42.
- +4 more secondary outcomes
Study Arms (7)
BI 3034701 treatment group 1
EXPERIMENTALBI 3034701 treatment group 2
EXPERIMENTALBI 3034701 treatment group 3
EXPERIMENTALBI 3034701 treatment group 4
EXPERIMENTALBI 3034701 treatment group 5
EXPERIMENTALBI 3034701 treatment group 6
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
BI 3034701
Eligibility Criteria
You may qualify if:
- 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
- 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.
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- 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
- 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.
- 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)
You may not qualify if:
- Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
- Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months before screening
- 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
- 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)
- A 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 starting within 3 months before screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, 35235, United States
Focus Clinical Research
West Hills, California, 91307, United States
Optimus U Corporation-Miami-69452
Miami, Florida, 33135, United States
Javara-Fayetteville-67354
Fayetteville, Georgia, 30214, United States
Monroe Biomedical Research - Louisville
Louisville, Kentucky, 40213, United States
Arcturus Healthcare - Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Centricity Research - Morehead City
Morehead City, North Carolina, 28557, United States
Accellacare-Wilmington-67123
Wilmington, North Carolina, 28401, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Tribe Clinical Research at Parkside OB-GYN, Greer
Greer, South Carolina, 29650, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520, United States
South Texas Research Institute-Edinburg-67012
Edinburg, Texas, 78539, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Data Point Clinical, LLC
Kirkland, Washington, 98034, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Southern Adelaide Diabetes and Endocrine Services
Oaklands Park, South Australia, 5046, Australia
Monash University
Box Hill, Victoria, 3128, Australia
Austin Health
Heidelberg, Victoria, 3048, Australia
Coastal Digestive Health & CDH Research Institute
Queensland, 4558, Australia
Ocean West Research Clinic (Surrey)
Surrey, British Columbia, V3Z 2N6, Canada
Hilltop Medical Clinic
Surrey, British Columbia, V4A 0C1, Canada
Dr. M. B. Jones Inc.
Victoria, British Columbia, V8V 4A1, Canada
Apex Trials (Guelph)
Guelph, Ontario, N1G 0B4, Canada
Winterberry Research Inc.
Hamilton, Ontario, L8J 0B6, Canada
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario, L8L 5G8, Canada
Milestone Research Inc.
London, Ontario, N5W 6A2, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
THEO Medical (Montreal)
Montreal, Quebec, H3M 1L3, Canada
Centre Medical Acadie (9109-0126 Quebec Inc)
Montreal, Quebec, H4N 2W2, Canada
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, J1E 0N8, Canada
Diex Recherche (Victoriaville)
Victoriaville, Quebec, G6P 3Z8, Canada
Diex Recherche (Quebec)
Québec, G1V 4T3, Canada
Huzhou Central Hospital
Huzhou, 313000, China
Center Hospital of Jinan
Jinan, 250013, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
First Hospital of Qinhuangdao
Qinhuangdao, 066099, China
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, 300070, China
Yichang Central People's Hospital
Yichang, 443008, China
Momentum Clinical Research Dunedin
Dunedin, Otago, 9016, New Zealand
Waitemata Clinical Research
Auckland, 0626, New Zealand
Auckland City Hospital
Grafton / Auckland, 1023, New Zealand
Clinical Trials New Zealand Ltd
Hamilton, 3204, New Zealand
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647, South Korea
Eulji University Hospital
Daejeon, 35233, South Korea
Chosun university hospital
Gwangju, 61453, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Fylde Coast Clinical Research
Blackpool, FY3 7EN, United Kingdom
The Garth Surgery
Guisborough, TS14 7DJ, United Kingdom
Velocity Clinical Research, High Wycombe
High Wycombe, HP11 2QW, United Kingdom
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Linthorpe Surgery
Middlesbrough, TS5 6HA, United Kingdom
Banbury Cross Health Centre
Oxford, OX16 9AD, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2026
First Posted
June 23, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
August 4, 2027
Study Completion (Estimated)
August 18, 2027
Last Updated
August 6, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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