Testing BI 456906 and Semaglutide for Obesity Management

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

This study is testing whether a new medication called BI 456906 works better than the approved weight loss drug semaglutide for helping adults with obesity manage their weight.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (industry)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT05202353 on ClinicalTrials.gov

What this trial studies

This clinical trial involves adults with obesity, specifically those with a BMI between 30 and 40 kg/m2. Participants will be randomly assigned to receive either BI 456906 or semaglutide, an approved weight loss medication, over a 17-week period. The study aims to assess how these treatments affect glucagon receptor activity in the liver and pancreas, which are crucial for appetite and weight regulation. Receptor occupancy will be measured using injectable tracers and imaging methods before and after the treatment period.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 30 and 40 kg/m2.

Not a fit: Patients with significant medical conditions or abnormalities in vital signs that deviate from the norm may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatments for obesity by enhancing our understanding of receptor activity related to weight regulation.

How similar studies have performed: Other studies have shown success with similar approaches in targeting glucagon receptor activity for obesity treatment.

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% (\>48 mmol/mol)
* 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

Where this trial is running

Amsterdam

• Amsterdam UMC, location VUMC — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions: Obesity