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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05202353




Registration number
NCT05202353
Ethics application status
Date submitted
10/01/2022
Date registered
21/01/2022
Date last updated
1/10/2024

Titles & IDs
Public title
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Scientific title
Open-label, Randomised, 4 Parallel-group, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjects With Obesity Using PET and MRI
Secondary ID [1] 0 0
2021-000363-76
Secondary ID [2] 0 0
1404-0047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 456906
Treatment: Drugs - Semaglutide

Experimental: Group 1: BI 456906 - PET/CT imaging for analysis of the liver

Experimental: Group 2: Semaglutide - PET/CT imaging for analysis of the liver

Active comparator: Group 3: BI 456906 - PET/CT imaging for analysis of the pancreas

Active comparator: Group 4: Semaglutide - PET/CT imaging for analysis of the pancreas


Treatment: Drugs: BI 456906
BI 456906

Treatment: Drugs: Semaglutide
Semaglutide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit
Timepoint [1] 0 0
up to Week 17
Secondary outcome [1] 0 0
Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT visit
Timepoint [1] 0 0
up to Week 17

Eligibility
Key inclusion criteria
* Healthy male or female subjects 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 65 years (inclusive)
* Body mass index (BMI) of = 30 and = 40 kg/m2 and body weight =70 kg and =150 kg
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Women of childbearing potential (WOCBP) must be willing and able to use two forms of effective contraception where at least one form is a highly effective method of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Resting heart rate > 100 beats per minute (bpm) and/or systolic blood pressure = 160 millimetre of mercury (mmHg) and/or diastolic blood pressure =95 mmHg at screening.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Subjects with the following abnormal values are not eligible for the trial participation:

* Low-density lipoprotein (LDL) > 160 mg/dL (4.15 mmol/L)
* total cholesterol >240 mg/dL (6.22 mmol/L)
* triglyceride >200 mg/dL (2.26 mmol/L)
* blood glucose > 126 mg/dl (7 mmol/L) fasting and/or glycated haemoglobin (HbA1c) >6.5%
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Subjects with type 1 and type 2 diabetes mellitus are not eligible for the trial
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1

Further criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/03/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Amsterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation. To measure the occupancy of these receptors, doctors use injectable tracers. Doctors visualise the binding of the tracers to these receptors with imaging methods.

Participants are put into 4 groups randomly, which means by chance. 2 groups get BI 456906 and 2 groups get semaglutide. Semaglutide is an approved medicine for body weight reduction. For 17 weeks, participants get injections under the skin. They either get BI 456906 twice a week or semaglutide once a week. The injected doses increase in small steps. Before and after 17 weeks of treatment, the receptor occupancy is determined.

Participants are in the study for up to 6 months. At the beginning and at the end of the treatment participants stay at the study site with an overnight stay. At the beginning, the study staff trains participants how to inject the study treatment at home. Participants who get BI 456906 visit the study site 18 times and have 19 visits at home. Participants who get semaglutide visit the study site 15 times and have 6 home visits. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial website
https://clinicaltrials.gov/study/NCT05202353
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05202353