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Completed

NCT Number: NCT06352424

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age of 40 to 60 years (inclusive)
  • 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
  • Body weight greater than or equal to 75 kg
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Male trial participants without need for contraception
  • 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

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • 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
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease
  • 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
  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Treatment and study plan

BI 456906

Drug

BI 456906

BI 1820237

Drug

BI 1820237

Placebo for BI 1820237

Drug

Placebo for BI 1820237

Placebo for BI 456906

Drug

Placebo for BI 456906

Primary outcomes

  1. 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

    Time frame: 32 days plus up to 8 weeks wash-out for each sequence, up to 51 weeks

    • 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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