A Phase II, randomized, double blind, parallel group,46 weeks dose-finding study of BI 456906 administered once weekly subcutaneously compared with placebo in patients with obesity or overweight

Phase 2

Completed

Conditions: Obesity
10003018

Registration Number: NL-OMON51000

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Adult >= 18 years and < 75 years of age at screening
2. Written informed consent
3. Obesity or Overweight defined as BMI >=27 kg/m2 at screening
4. A minimum absolute body weight of 70 kg for females and 80 kg for males at
screening
5. Male or female participants. Women of childbearing potential must be willing
and able to use two forms of effective contraception
6. Patients must have undergone at least one previous unsuccessful nonsurgical
weight-loss attempt per investigator*s judgement

Exclusion Criteria

1. Body weight change of over +/- 5% or more in the past 12 weeks prior to
randomization. There must be documentation of weight in the past 12 weeks
before randomization.
2. Obesity induced by an endocrinologic disorder (e.g. Cushing Syndrome)
3. A HbA1c >= 6.5% at screening or diagnosed with type 1 or type 2 diabetes
mellitus
4. Exposure to GLP-1Ra based therapies within three months prior to screening

Further criteria apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Percentage change in body weight (%) from baseline to week 46</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- Weight loss of >= 5% of baseline weight at week 46<br /><br>- Weight loss of >= 10% of baseline weight at week 46<br /><br>- Weight loss of >= 15% of baseline weight at week 46<br /><br>- Absolute change in body weight (kg) from baseline to week 46<br /><br>- Absolute change in waist circumference (cm) from baseline to week 46<br /><br>- Absolute change in systolic blood pressure (mmHg) from baseline to week 46<br /><br>- Absolute change in diastolic blood pressure (mmHg) from baseline to week 46</p><br>