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

Launched by BOEHRINGER INGELHEIM · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how a new medication called BI 456906 affects certain receptors in the liver and pancreas that help control appetite and weight in adults with obesity. The study is open to individuals aged 18 to 65 who have a body mass index (BMI) between 30 and 40, which means they are classified as overweight or obese. Participants will be randomly assigned to receive either BI 456906 or semaglutide, an approved weight-loss medicine, for 17 weeks through injections. The study aims to see how well these medications bind to the receptors in the body, which could help in managing weight.

Participants can expect to be involved in the trial for up to six months, which includes training on how to administer the injections at home and regular health check-ups. Those receiving BI 456906 will have more visits at the study site compared to those receiving semaglutide. To join the study, participants must be generally healthy, without serious medical issues, and not have diabetes. It’s important to note that women who could become pregnant will need to use effective birth control methods during the trial. If you think you might be eligible and are interested in participating, this study could help contribute to new treatments for obesity.

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Eligibility 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 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
• 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