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A Study to Test Different Doses of BI 456906 in Patients With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03591718
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

Condition or disease Intervention/treatment Phase
Obesity Drug: BI 456906 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : September 13, 2019
Estimated Study Completion Date : October 18, 2019

Arm Intervention/treatment
Experimental: BI 456906 Drug: BI 456906
Solution for injection

Experimental: Placebo Drug: Placebo
solution for injection




Primary Outcome Measures :
  1. Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme [ Time Frame: Up to 69 days ]

Secondary Outcome Measures :
  1. AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) [ Time Frame: Up to 168 hours ]
  2. Cmax (maximum measured concentration of the analyte in plasma) after first dose [ Time Frame: Up to 69 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients ≥ 18 years and < 70 years of age at screening.
  • Body Mass Index (BMI) ≥ 27 kg/m2 and <40 kg/m2 at screening.
  • A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening.
  • HbA1c <6.5%.
  • Further inclusion criteria apply

Exclusion Criteria:

  • Females
  • Supine blood pressure (BP) ≥160/100 mmHg at screening
  • Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591718


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Germany
Profil Mainz GmbH & Co. KG Recruiting
Mainz, Germany, 55116
Contact: Leona Plum-Mörschel    4961312162702    Leona.Plum-Moerschel@profil.com   
Profil Institut für Stoffwechselforschung GmbH Recruiting
Neuss, Germany, 41460
Contact: Jorge Arrubla    +49 (2131) 4018305    Jorge.Arrubla@profil.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03591718     History of Changes
Other Study ID Numbers: 1404-0003
2018-000250-22 ( EudraCT Number )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms