NCT07754474

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2027

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Up to 113 days

Secondary Outcomes (2)

  • Area under the concentration-time curve of the analyte in plasma over the dosing interval of 0 to 168 hours (AUCτ) following multiple doses of BI 3034701

    Up to 106 days

  • Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701

    Up to 106 days

Study Arms (3)

Dose Group 1

EXPERIMENTAL

Low dose of BI 3034701.

Drug: BI 3034701

Dose Group 2

EXPERIMENTAL

High dose of BI 3034701.

Drug: BI 3034701

Placebo

PLACEBO COMPARATOR

Placebo to BI 3034701.

Drug: Placebo

Interventions

BI 3034701DRUG

BI 3034701

Dose Group 1Dose Group 2
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age of 18 to 74 years (inclusive)
  • Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)
  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hVIVO Mannheim

Mannheim, 68167, Germany

Location

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

January 17, 2027

Last Updated

August 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations

DE(1)