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

NCT04447261 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1427-00022020-000342-34
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with drug-related adverse events

  Up to 40 days

Secondary Outcomes (8)

• AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose)

  Up to 35 days

• Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)

  Up to 35 days

• AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)

  Up to 35 days

• Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)

  Up to 35 days

• AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)

  Up to 35 days

Study Arms (2)

BI 1356225

EXPERIMENTAL

Drug: BI 1356225

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1356225 DRUG

BI 1356225

BI 1356225

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: June 30, 2020
• Primary Completion: April 25, 2021
• Study Completion: April 25, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)