ObesityPhase 2NCT07662122
A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
A Phase 2 study testing BI 3034701 in people with Obesity and Overweight, run by Boehringer Ingelheim at 54 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- BI 3034701
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 54 sitesin 6 countries
- Study dates
- 30 Jun 2026to 10 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- 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.
Trial locations and contacts
54 sites in 6 countries.
54 sites in 6 countries
United States19 sites
Texas Diabetes and Endocrinology - Central Austin
Austin, Texas, 78731
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, 35235
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303
South Texas Research Institute-Edinburg-67012
Edinburg, Texas, 78539
Lillestol Research, LLC
Fargo, North Dakota, 58104
Javara-Fayetteville-67354
Fayetteville, Georgia, 30214
Tribe Clinical Research at Parkside OB-GYN, Greer
Greer, South Carolina, 29650
Data Point Clinical, LLC
Kirkland, Washington, 98034
Monroe Biomedical Research - Louisville
Louisville, Kentucky, 40213
Optimus U Corporation-Miami-69452
Miami, Florida, 33135
Centricity Research - Morehead City
Morehead City, North Carolina, 28557
Rainier Clinical Research Center
Renton, Washington, 98057
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Clinvest Research LLC
Springfield, Missouri, 65807
Arcturus Healthcare - Troy Internal Medicine Research Division
Troy, Michigan, 48098
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226
Focus Clinical Research
West Hills, California, 91307
Accellacare-Wilmington-67123
Wilmington, North Carolina, 28401
Canada15 sites
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Apex Trials (Guelph)
Guelph, Ontario, N1G 0B4
Winterberry Research Inc.
Hamilton, Ontario, L8J 0B6
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario, L8L 5G8
Milestone Research Inc.
London, Ontario, N5W 6A2
THEO Medical (Montreal)
Montreal, Quebec, H3M 1L3
Centre Medical Acadie (9109-0126 Quebec Inc)
Montreal, Quebec, H4N 2W2
Diex Recherche (Quebec)
Québec, G1V 4T3
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, J1E 0N8
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2
Ocean West Research Clinic (Surrey)
Surrey, British Columbia, V3Z 2N6
Hilltop Medical Clinic
Surrey, British Columbia, V4A 0C1
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Dr. M. B. Jones Inc.
Victoria, British Columbia, V8V 4A1
Diex Recherche (Victoriaville)
Victoriaville, Quebec, G6P 3Z8
China8 sites
Huzhou Central Hospital
Huzhou, 313000
Center Hospital of Jinan
Jinan, 250013
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
First Hospital of Qinhuangdao
Qinhuangdao, 066099
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, 300070
Yichang Central People's Hospital
Yichang, 443008
United Kingdom6 sites
Fylde Coast Clinical Research
Blackpool, FY3 7EN
The Garth Surgery
Guisborough, TS14 7DJ
Velocity Clinical Research, High Wycombe
High Wycombe, HP11 2QW
Leicester General Hospital
Leicester, LE5 4PW
Linthorpe Surgery
Middlesbrough, TS5 6HA
Banbury Cross Health Centre
Oxford, OX16 9AD
Australia3 sites
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128
Coastal Digestive Health & CDH Research Institute
Maroochydore, Queensland, 4558
Southern Adelaide Diabetes and Endocrine Services (SADES)
Oaklands Park, South Australia, 5046
New Zealand3 sites
Waitemata Clinical Research
Auckland, 0626
Momentum Clinical Research Dunedin
Central Dunedin, Dunedin, 9016
Momentum Clinical Research Wellington
Mount Cook, Wellington Region, 6021
About this study
Official title: 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.
- Conditions
- Obesity, Overweight
- Being tested
- BI 3034701, Placebo matching BI 3034701
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3034701Drug
BI 3034701
Placebo matching BI 3034701Drug
Placebo matching BI 3034701
| Study group | Role | What they receive |
|---|---|---|
| BI 3034701 treatment group 1 | Experimental | Not described Receives: Drug: BI 3034701 |
| BI 3034701 treatment group 2 | Experimental | Not described Receives: Drug: BI 3034701 |
| BI 3034701 treatment group 3 | Experimental | Not described Receives: Drug: BI 3034701 |
| BI 3034701 treatment group 4 | Experimental | Not described Receives: Drug: BI 3034701 |
| BI 3034701 treatment group 5 | Experimental | Not described Receives: Drug: BI 3034701 |
| BI 3034701 treatment group 6 | Experimental | Not described Receives: Drug: BI 3034701 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3034701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline at Week 42 [%]
Measured: Baseline and at Week 42.
Secondary outcomes (9)
Achievement of weight loss of ≥5% of baseline weight at Week 42
Measured: Baseline and at Week 42.
Achievement of weight loss of ≥10% of baseline weight at Week 42
Measured: Baseline and at Week 42.
Achievement of weight loss of ≥15% of baseline weight at Week 42
Measured: Baseline and at Week 42.
Achievement of weight loss of ≥20% of baseline weight at Week 42
Measured: Baseline and at Week 42.
Absolute change from baseline at Week 42 in body weight [kg]
Measured: Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist circumference [cm]
Measured: Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist-to-height ratio (WHtR) [dimensionless ratio]
Measured: Baseline and at Week 42.
Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg]
Measured: Baseline and at Week 42.
Absolute change from baseline at Week 42 in diastolic blood pressure (DBP) [mmHg]
Measured: Baseline and at Week 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start30 Jun 2026
- Primary completion26 Jun 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662122
- Sponsor's protocol ID
- 1507-0002
- Other IDs
- U1111-1335-5538
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07662122
- Acronym / sponsor ID
- 1507-0002
- Conditions
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BI 3034701 treatment group 1 | Experimental | Drug: BI 3034701 |
| BI 3034701 treatment group 2 | Experimental | Drug: BI 3034701 |
| BI 3034701 treatment group 3 | Experimental | Drug: BI 3034701 |
| BI 3034701 treatment group 4 | Experimental | Drug: BI 3034701 |
| BI 3034701 treatment group 5 | Experimental | Drug: BI 3034701 |
| BI 3034701 treatment group 6 | Experimental | Drug: BI 3034701 |
| Placebo | Placebo comparator | Drug: Placebo matching BI 3034701 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3034701BI 3034701 | Drug | BI 3034701 treatment group 1, BI 3034701 treatment group 2, BI 3034701 treatment group 3, BI 3034701 treatment group 4, BI 3034701 treatment group 5, BI 3034701 treatment group 6 |
| Placebo matching BI 3034701Placebo matching BI 3034701 | Drug | Placebo |
Primary outcome
Percentage change in body weight from baseline at Week 42 [%]
Time frame: Baseline and at Week 42.
9 secondary outcomes
Achievement of weight loss of ≥5% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥10% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥15% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥20% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in body weight [kg]
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist circumference [cm]
Time frame: 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.
Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg]
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 3034701 in people with Obesity and Overweight, run by Boehringer Ingelheim at 54 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, China, United Kingdom, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline at Week 42 [%] (time frame: Baseline and at Week 42.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.