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A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

Primary Purpose

Healthy, Obesity

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 1820237
semaglutide
Placebo
BI 456906
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female subjects with obesity/overweight (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 55 years (inclusive) Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator Body weight greater than or equal to 75 kg Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply. 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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, bariatric surgery or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (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

Sites / Locations

  • CRS Clinical Research Services Mannheim GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

BI 1820237 treatment group

Placebo group

BI 1820237 + semaglutide treatment group

placebo + semaglutide group

BI 1820237 + BI 456906 treatment group

placebo + BI 456906 group

Arm Description

Outcomes

Primary Outcome Measures

Percentage of treatment-emergent adverse events
assessed as drug-related by the investigator

Secondary Outcome Measures

Area under the concentration-time curve of BI 1820237 in plasma over the time interval from 0 to 168 hours after administration of BI 1820237 or placebo (AUC0-168)
Maximum measured concentration of BI 1820237 in plasma (Cmax)

Full Information

First Posted
February 21, 2023
Last Updated
July 11, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05751226
Brief Title
A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Titration Schedules of Subcutaneous Doses of BI 1820237 Alone or Together With Either Semaglutide or BI 456906 in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Multiple Dose, Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
April 25, 2024 (Anticipated)
Study Completion Date
April 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is open to adults between 18 and 55 years of age who are living with overweight or obesity. People with a body mass index (BMI) from 27 to 40 kg/m2 can join the study. The main purpose of this study is to find out how a medicine called BI 1820237 is tolerated by people with overweight or obesity when taken alone or in combination with a medicine called semaglutide or with a medicine called BI 456906. Participants are divided into different groups. All participants in the study either take different doses of BI 1820237 or placebo. Some of the groups take either semaglutide or BI 456906 in addition. Each participant has an equal chance of being in each group. All participants receive the study medicines as injections under the skin once a week for almost 5 months. Placebo injections look like BI 1820237 injections, but do not contain any medicine. Semaglutide is medicine that is already used for overweight or obesity. BI 456906 is another medicine that is being developed for the treatment of overweight and obesity. Participants are in the study for about 7 months. During this time, they visit the study site regularly. For some of the visits, the participants remain at the study site for 1 or 2 nights. At the study visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1820237, semaglutide, or BI 456906.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 1820237 treatment group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
BI 1820237 + semaglutide treatment group
Arm Type
Experimental
Arm Title
placebo + semaglutide group
Arm Type
Active Comparator
Arm Title
BI 1820237 + BI 456906 treatment group
Arm Type
Experimental
Arm Title
placebo + BI 456906 group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BI 1820237
Intervention Description
BI 1820237
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
semaglutide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BI 456906
Intervention Description
BI 456906
Primary Outcome Measure Information:
Title
Percentage of treatment-emergent adverse events
Description
assessed as drug-related by the investigator
Time Frame
Up to 180 days
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve of BI 1820237 in plasma over the time interval from 0 to 168 hours after administration of BI 1820237 or placebo (AUC0-168)
Time Frame
Up to 141 days
Title
Maximum measured concentration of BI 1820237 in plasma (Cmax)
Time Frame
Up to 141 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects with obesity/overweight (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 55 years (inclusive) Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator Body weight greater than or equal to 75 kg Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply. 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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, bariatric surgery or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
CRS Clinical Research Services Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.mystudywindow.com/msw/datatransparency
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906

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