A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: BI 1356225

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447261

2020-000342-34 (EudraCT Number)

1427-0002

Details and patient eligibility

About

The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated

Enrollment: 87 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Male and female patients, age ≥ 18 and < 70
• Body Mass Index ≥ 27 kg/m2 and < 40 kg/m2 at screening
• Stable body weight (defined as no more than 5% change) within 3 months prior to screening
• further inclusion criteria apply

Exclusion criteria

• Females of childbearing potential
• Clinically relevant concomitant disease per investigator judgment
• Any condition or disease requiring permanent pharmacotherapy during the trial
• Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months
• further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

BI 1356225

Experimental group

Treatment:

Drug: BI 1356225

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo