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

• Status: Not yet recruiting
• Trial end date: 2023-05-12
• Target enrollment: 0
• Participant gender: All

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 density 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 liraglutide. Liraglutide is an approved medicine for body weight reduction.

For 14 weeks, participants get as injections BI 456906 two times a week or liraglutide daily. The doses of BI 456906 and liraglutide get higher over time. After 14 weeks of treatment, the receptor density in the liver, as well as in pancreas is compared between different groups. For group 2, doctors look at the receptor density in the brain. To do so, doctors label the receptors and visualise them with an imaging method (PET/CT scans).

Participants are in the study for about 22 weeks. Depending on the group, they visit the study site 13 to 20 times. And 4 or 5 visits are done at the participant's home. The doctors also regularly check participants' health and take note of any unwanted effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Liraglutide

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 highly effective methods 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 blood pressure ≥ 160/ 95 millimetre of mercury (mmHg) at Visit 1

• 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

• total cholesterol >240 mg/dL

• triglyceride >200 mg/dL

• blood glucose > 126 mg/dl 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

• Cholecystectomy 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 Further criteria apply