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

Obesity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352424
• Other study ID #: 1458-0006
• Secondary ID: 2023-506233-30-0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 15, 2024
• Est. completion date: December 9, 2024

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 9, 2024
• Est. primary completion date: December 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• BI 456906
BI 456906
• BI 1820237
BI 1820237
• Placebo for BI 1820237
Placebo for BI 1820237
• Placebo for BI 456906
Placebo for BI 456906

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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