A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide

Healthy Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903509
• Other study ID #: 1458-0001
• Secondary ID: 2021-000327-13
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: August 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of liraglutide in male subjects with overweight/obesity (otherwise healthy) following subcutaneous administration of single rising doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male subjects with overweight/obesity (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 50 years (inclusive)

• Body mass index (BMI) of 25.0 to 34.9 kg/m2 (inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator

• Body weight greater than or equal to 70 kg

• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medications except appendectomy or simple hernia repair

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Drug:
• BI 1820237
BI 1820237
• Placebo
Placebo
• Saxenda®
Saxenda®
• Paracetamol-ratiopharm®
Paracetamol-ratiopharm®

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with drug-related adverse events		up to 48 days
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 38 days
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)		up to 38 days

External Links

•   Related Info