A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity

A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)

The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: BI 1820237; Drug: BI 456906; Drug: Placebo for BI 1820237; Drug: Placebo for BI 456906

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects with obesity/overweight (otherwise healthy) 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
2. Age of 40 to 60 years (inclusive)
3. Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive). Overweight/obesity should be due to excess adipose tissue, as judged by the Investigator
4. Body weight greater than or equal to 75 kg
5. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
6. Male trial participants without need for contraception

7. Female trial participants, only if any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 2 months after last administration of trial medication are met:

   • Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (intravaginal or transdermal)
   • Bilateral tubal occlusion
   • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm according to verbal confirmation of female participant) and provided that partner is the sole sexual partner of the trial participant
   • Abstention from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable.

Or female subject meets any of the following criteria:

• Permanent sterilisation by hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy
• Woman is postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm and assessed as clinically relevant by the investigator
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-B-C-D; A: Treatment Test 1 (T1): BI 1820237 + Placebo for BI 456906; B: Treatment Test 2 (T2): BI 456906 + Placebo for BI 1820237; C: Treatment Test 3 (T3): BI 1820237 + BI 456906; D: Treatment Reference (R1, R2): Placebo for BI 1820237 + Placebo for BI 456906	Drug: BI 1820237; BI 1820237; Drug: BI 456906; BI 456906; Drug: Placebo for BI 1820237; Placebo for BI 1820237; Drug: Placebo for BI 456906; Placebo for BI 456906
Experimental: B-D-A-C	Drug: BI 1820237; BI 1820237; Drug: BI 456906; BI 456906; Drug: Placebo for BI 1820237; Placebo for BI 1820237; Drug: Placebo for BI 456906; Placebo for BI 456906
Experimental: C-A-D-B	Drug: BI 1820237; BI 1820237; Drug: BI 456906; BI 456906; Drug: Placebo for BI 1820237; Placebo for BI 1820237; Drug: Placebo for BI 456906; Placebo for BI 456906
Experimental: D-C-B-A	Drug: BI 1820237; BI 1820237; Drug: BI 456906; BI 456906; Drug: Placebo for BI 1820237; Placebo for BI 1820237; Drug: Placebo for BI 456906; Placebo for BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo	in the fasted state in response to food visual stimuli and nutrient-specific food preference; assessed by task based functional magnetic resonance imaging (fMRI) in the whole brain	32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 1458-0006; 2023-506233-30-01 (Registry Identifier: CTIS (EU)); U1111-1293-4672 (Registry Identifier: WHO Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No