NCT07754474 A Study to Test How Well Different and Multiple Doses of BI 3034701 Are Tolerated in People Living With Overweight or Obesity
| NCT ID | NCT07754474 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2026-09-01 with a primary completion date of 2027-06-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objectives of this trial are to investigate safety, tolerability of alternative dose titration strategies and pharmacokinetics (PK) of BI 3034701 in participants with overweight / obesity and at least one weight related co-morbidity following subcutaneous administration.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07754474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07754474 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07754474 currently recruiting?
Yes, NCT07754474 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT07754474 trial being conducted?
This trial is being conducted at Mannheim, Germany.
Who is sponsoring the NCT07754474 clinical trial?
NCT07754474 is sponsored by Boehringer Ingelheim. The trial plans to enroll 70 participants.