Clinical trial NCT04667377: A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change in Body Weight From Baseline to Week 46
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary outcomes:
measure: Weight Loss of ≥ 5% of Baseline Weight at Week 46
timeFrame: At baseline and at Week 46.
measure: Weight Loss of ≥ 10% of Baseline Weight at Week 46
timeFrame: At baseline and at Week 46.
measure: Weight Loss of ≥ 15% of Baseline Weight at Week 46
timeFrame: At baseline and at Week 46.
measure: Absolute Change in Body Weight From Baseline to Week 46
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
measure: Absolute Change in Waist Circumference From Baseline to Week 46
timeFrame: Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
measure: Absolute Change in Systolic Blood Pressure From Baseline to Week 46
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
measure: Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Fargo
country: United States
facility: Valley Weight Loss Clinic
state: North Dakota
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Columbia
country: United States
facility: TLM Medical Services, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Arlington
country: United States
facility: Washington Center for Weight Management and Research, Inc.
state: Virginia
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Camperdown
country: Australia
facility: The Boden Initiative
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Ringwood
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
city: Cambridge
country: Canada
facility: Joanne F Liutkus Medicine Professional Corporation
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital Capital Medical University
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Berlin
country: Germany
facility: Klinische Forschung Berlin GbR
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St.Mary's Hospital
city: Almere
country: Netherlands
facility: EB Flevoresearch
city: Beek
country: Netherlands
facility: PT & R
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Zwijndrecht
country: Netherlands
facility: Albert SchweitzerZiekenhuis
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Newtown Wellington NZ
country: New Zealand
facility: P3 Research
city: Katowice
country: Poland
facility: Salvia Lekston I Madej Sp. J.
city: Poznan
country: Poland
facility: Metabolic Health Center Pawel Bogdanski
city: Borås
country: Sweden
facility: Ladulaas Kliniska Studier
city: Göteborg
country: Sweden
facility: Forskningsenheten Carlanderska
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre, Rotherham
Study officials:
References: