A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: BI 456906; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04667377

1404-0036

2020-002479-37 (EudraCT Number)

Details and patient eligibility

About

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 purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight.

Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine.

Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

Enrollment: 387 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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387 participants in 5 patient groups, including a placebo group

0.6 mg BI 456906

Experimental group

Treatment:

Drug: BI 456906

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo

2.4 mg BI456906

Experimental group

Treatment:

Drug: BI 456906

3.6 mg BI 456906

Experimental group

Treatment:

Drug: BI 456906

4.8 mg BI 456906

Experimental group

Treatment:

Drug: BI 456906