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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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; Semaglutide

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT05202353
• Other Study ID Numbers: 1404-0047; 2021-000363-76 ( EudraCT Number )
• First Posted: January 21, 2022
• 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

• 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:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight