Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
