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A Study in People With Obesity to Test the Effects of Different Doses of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver

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ClinicalTrials.gov Identifier: NCT05202353
Recruitment Status : Not yet recruiting
First Posted : January 21, 2022
Last Update Posted : March 8, 2023
Information provided by (Responsible Party):
Boehringer Ingelheim

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 kg or higher can join the study.

The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of the glucagon receptor in the liver. These receptors are involved in appetite and weight regulation.

Participants are put into 3 groups randomly, which means by chance. Participants in groups 1 and 2 get BI 456906. Participants in group 3 get semaglutide. Semaglutide is an approved medicine for body weight reduction.

For 17 weeks, participants get as injections BI 456906 two times a week or semaglutide once a week. The doses of BI 456906 and semaglutide get higher over time. After 17 weeks of treatment, the receptor occupancy in the liver, as well as in pancreas is compared between different groups. To do so, doctors label the receptors and visualise them with an imaging method (PET/CT scans).

Participants are in the study for about 25 weeks. Depending on the group, they have 21 to 25 visits. And 5 to 7 visits of all are done at the participant's home. The doctors also regularly check participants' health and take note of any unwanted effects.

Condition or disease Intervention/treatment Phase
Obesity Drug: BI 456906 Drug: Semaglutide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label,Randomised, 3 Parallel-group, Phase I Clinical Trial to Investigate BI 456906occupancy of Glucagon Receptorsin Liver and Glucagon-like Peptide 1receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjectswith Obesityusing PET and MRI
Estimated Study Start Date : June 15, 2023
Estimated Primary Completion Date : November 20, 2024
Estimated Study Completion Date : December 18, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Group 1: BI 456906 - less imaging procedures Drug: BI 456906
BI 456906

Experimental: Group 2: BI 456906 - more imaging procedures Drug: BI 456906
BI 456906

Active Comparator: Group 3: Semaglutide Drug: Semaglutide

Primary Outcome Measures :
  1. Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit [ Time Frame: at Week 17 ]

Secondary Outcome Measures :
  1. Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT [ Time Frame: at Week 17 ]
  2. Percentage of GCG receptors occupancy in the liver with BI 456906 using PET at Visit 8 [ Time Frame: at Week 3 ]
  3. Percentage of GCG receptors occupancy in the liver with BI 456906 using PET at Visit 17 [ Time Frame: at Week 11 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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

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 or stroke), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202353

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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05202353    
Other Study ID Numbers: 1404-0047
2021-000363-76 ( EudraCT Number )
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight