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New treatment option for Obesity
Official title A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
ClinicalTrials.gov ID: NCT07662122
What this study is testing
What is BI 3034701?
BI 3034701 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Male or female, age ≥18 to \ 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...
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on...
You likely can't join 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...
- Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for...
- 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...
See the full eligibility criteria
- Male or female, age ≥18 to \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Hamden, Connecticut, United States
- Miami, Florida, United States
- Fayetteville, Georgia, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Troy, Michigan, United States
- City of Saint Peters, Missouri, United States
- Springfield, Missouri, United States
- Morehead City, North Carolina, United States
- Wilmington, North Carolina, United States
- Fargo, North Dakota, United States
- Greer, South Carolina, United States
- Austin, Texas, United States
- Brownsville, Texas, United States
- Edinburg, Texas, United States
- San Antonio, Texas, United States
- Renton, Washington, United States
- Wauwatosa, Wisconsin, United States
- Camperdown, New South Wales, Australia
+ 39 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Hamden, Connecticut, United States; Miami, Florida, United States; Fayetteville, Georgia, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States and 53 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.