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

NCT04903509 | Completed Phase 1

• 2 other identifiers: 1458-00012021-000327-13
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with drug-related adverse events

  up to 48 days

Secondary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 38 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 38 days

Study Arms (4)

BI 1820237

EXPERIMENTAL

Part 1 and part 2 of the trial.

Drug: BI 1820237; Drug: Paracetamol-ratiopharm®

Placebo

PLACEBO COMPARATOR

Part 1 and part 2 of the trial.

Drug: Placebo; Drug: Paracetamol-ratiopharm®

BI 1820237 + liraglutide

EXPERIMENTAL

Part 3 of the trial.

Drug: BI 1820237; Drug: Saxenda®; Drug: Paracetamol-ratiopharm®

Placebo + liraglutide

PLACEBO COMPARATOR

Part 3 of the trial.

Drug: Placebo; Drug: Saxenda®; Drug: Paracetamol-ratiopharm®

Interventions

BI 1820237 DRUG

BI 1820237

BI 1820237; BI 1820237 + liraglutide

Placebo DRUG

Placebo

Placebo; Placebo + liraglutide

Saxenda® DRUG

Saxenda®

Also known as: Liraglutide

BI 1820237 + liraglutide; Placebo + liraglutide

Paracetamol-ratiopharm® DRUG

Paracetamol-ratiopharm®

Also known as: Paracetamol

BI 1820237; BI 1820237 + liraglutide; Placebo; Placebo + liraglutide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Liraglutide; Acetaminophen

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Within the central electrocardiogram (ECG) lab, the staff involved with interval measurements will be blinded with respect to the treatment and also with regard to the recording date and time as well as planned time points of the ECGs. The interval measurements for a given subject will be performed in a random and blinded sequence by a single technician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 26, 2021
• Study Start: June 8, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)