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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04903509

Collaborator

(none)

Enrollment

Location

Arms

14.7

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1820237 Drug: Placebo Drug: Saxenda® Drug: Paracetamol-ratiopharm®	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 8, 2021

Anticipated Primary Completion Date :

Aug 29, 2022

Anticipated Study Completion Date :

Aug 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1820237 Part 1 and part 2 of the trial.	Drug: BI 1820237 BI 1820237 Drug: Paracetamol-ratiopharm® Paracetamol-ratiopharm® Other Names: Paracetamol
Placebo Comparator: Placebo Part 1 and part 2 of the trial.	Drug: Placebo Placebo Drug: Paracetamol-ratiopharm® Paracetamol-ratiopharm® Other Names: Paracetamol
Experimental: BI 1820237 + liraglutide Part 3 of the trial.	Drug: BI 1820237 BI 1820237 Drug: Saxenda® Saxenda® Other Names: Liraglutide Drug: Paracetamol-ratiopharm® Paracetamol-ratiopharm® Other Names: Paracetamol
Placebo Comparator: Placebo + liraglutide Part 3 of the trial.	Drug: Placebo Placebo Drug: Saxenda® Saxenda® Other Names: Liraglutide Drug: Paracetamol-ratiopharm® Paracetamol-ratiopharm® Other Names: Paracetamol

Outcome Measures

Primary Outcome Measures

Percentage of subjects with drug-related adverse events [up to 48 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Mannheim GmbH	Mannheim		Germany	68167

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04903509

Other Study ID Numbers:

1458-0001
2021-000327-13

First Posted:

May 26, 2021

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Acetaminophen

Liraglutide

Study Results

No Results Posted as of Aug 11, 2022