How well different and multiple doses of BI 3034701 are tolerated in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating safety, tolerability of alternative dose-titration strategies, and pharmacokinetics of BI 3034701 administered subcutaneously in adults with overweight or obesity and at least one weight-related comorbidity. Participants will receive BI 3034701 or placebo to determine how the drug behaves in the body and how tolerable the dosing regimens are. Key eligibility includes age 18-74, BMI 27.0-39.9 kg/m², and medical assessments confirming no clinically significant abnormalities beyond the weight-related condition. Exclusion criteria include abnormal findings in physical exams, vital signs, ECG, or labs that are not explained by the weight-related complication. The study is led by Boehringer Ingelheim with hVIVO Mannheim as the site.

Why it matters

Who can join: the full rules

Inclusion criteria :

1. Male or female trial participant, overweight/obese with one weight related complication but otherwise healthy according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 74 years (inclusive)
3. Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
5. Further inclusion criteria apply.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator, unless confirming the weight related complication
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm, unless arterial hypertension is the weight related complication in the context of this trial
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and may interfere with trial participation or interpretation of the results, other than abnormalities attributable to the permitted weight-related complications
4. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI)) at screening or trial participants requiring dialysis
5. Further exclusion criteria apply.

Where it's running

• hVIVO Mannheim
  Mannheim, Germany Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.