Testing BI 3034701 against a placebo for obesity
Official title: 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
- Phase 2
- 7 groups
- Sites in Québec, Surrey and 10 more cities
- Recruiting
Interventions
- Medication
BI 3034701
BI 3034701
- Medication
Placebo matching BI 3034701
Placebo matching BI 3034701
Canadian Sites (15)
15 of 15 recruiting
- Recruiting
Ocean West Research Clinic (Surrey)
Surrey, British Columbia
- Recruiting
Hilltop Medical Clinic
Surrey, British Columbia
- Recruiting
Dr. M. B. Jones Inc.
Victoria, British Columbia
- Recruiting
Apex Trials (Guelph)
Guelph, Ontario
- Recruiting
Winterberry Research Inc.
Hamilton, Ontario
- Recruiting
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario
- Recruiting
Milestone Research Inc.
London, Ontario
- Recruiting
Stouffville Medical Research Institute Inc.
Stouffville, Ontario
- Recruiting
Canadian Phase Onward Inc.
Toronto, Ontario
- Recruiting
Diex Recherche (Quebec)
Québec
- Recruiting
Ecogene-21
Chicoutimi, Quebec
- Recruiting
THEO Medical (Montreal)
Montreal, Quebec
- Recruiting
Centre Medical Acadie (9109-0126 Quebec Inc)
Montreal, Quebec
- Recruiting
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec
- Recruiting
Diex Recherche (Victoriaville)
Victoriaville, Quebec
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female, age ≥18 to \<75 years at the time of signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, and at least the legal age of consent in countries where it is \>18 years
- +Body mass index (BMI) ≥30 kg/m² at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, 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
- +In the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 protocolProtocolThe detailed plan a study must follow.Read more → (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)
- +Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth controlControl groupThe group a new treatment is measured against.Read more → 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.
Exclusion
- −Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months 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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → visit Further exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 7 groups in this study.
Groups A, B, C, D, E and F receive BI 3034701.
Registry label: A: BI 3034701 treatment group 1 · B: BI 3034701 treatment group 2 · C: BI 3034701 treatment group 3 · D: BI 3034701 treatment group 4 · E: BI 3034701 treatment group 5 · F: BI 3034701 treatment group 6
Group G, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo matching BI 3034701.
Registry label: G: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 74 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 300 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Week 42.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage change in body weight from baselineBaselineYour starting measurements, taken before treatment begins.Read more → at Week 42 [%] — measured over Baseline and at Week 42.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07662122 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BI 3034701Drug
BI 3034701
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching BI 3034701Drug
Placebo matching BI 3034701
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 74 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 74 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Week 42..
The study as a whole is currently expected to finish around 2027-08-18.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Québec, Canada; Surrey, British Columbia, Canada; Victoria, British Columbia, Canada; Guelph, Ontario, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Arcturus Healthcare - Troy Internal Medicine Research Division
Troy, Michigan, United States
Data Point Clinical, LLC
Kirkland, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.