Status:
COMPLETED
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The pur...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult ≥ 18 years and \< 75 years of age at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Obesity or Overweight defined as BMI ≥27 kg/m2 at screening
- A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
- Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement
- Exclusion criteria:
- 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.
- Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)
- A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening
- Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period
- History of major depressive disorder within 2 years before randomization
- Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 \[PHQ-9\] score ≥15) at screening and/or during screening period
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening
- Chronic or relevant acute infections (including but not limited to respiratory tract infections, urinary tract infection, bladder infection, enterocolitis, abscess, tuberculosis, meningitis, influenza, Epstein-Barr virus, HIV/AIDS, and hepatitis B or C, and severe acute respiratory syndrome coronavirus type 19 (SARS CoV-2) (as confirmed by Polychain reaction (PCR) test)), within 2 weeks from screening or during screening.
- Further exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT04667377
Start Date
March 8 2021
End Date
October 7 2022
Last Update
November 2 2023
Active Locations (43)
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1
Diablo Clinical Research
Walnut Creek, California, United States, 94598
2
L-MARC Research Center
Louisville, Kentucky, United States, 40213
3
Lucas Research, Inc.
Morehead City, North Carolina, United States, 28557
4
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401