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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667377
• Other study ID #: 1404-0036
• Secondary ID: 2020-002479-37
• Status: Completed
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: October 7, 2022

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: October 7, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• BI 456906
BI 456906
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Boden Initiative	Camperdown	New South Wales
Australia	Eastern Clinical Research Unit	East Ringwood	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Belgium	UZ Leuven	Leuven
Canada	Joanne F Liutkus Medicine Professional Corporation	Cambridge	Ontario
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Bluewater Clinical Research	Sarnia	Ontario
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
China	Beijing Chao-Yang Hospital	Beijing
China	Beijing Luhe Hospital Capital Medical University	Beijing
China	The First Hospital of Jilin University	Changchun
China	Wuhan Union Hospital	Wuhan
Germany	Klinische Forschung Berlin GbR	Berlin
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St.Mary's Hospital	Seoul
Netherlands	EB Flevoresearch	Almere
Netherlands	PT & R	Beek
Netherlands	Franciscus Gasthuis	Rotterdam
Netherlands	Albert SchweitzerZiekenhuis	Zwijndrecht
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	P3 Research	Newtown Wellington NZ
Poland	Salvia Lekston I Madej Sp. J.	Katowice
Poland	Metabolic Health Center Pawel Bogdanski	Poznan
Sweden	Ladulaas Kliniska Studier	Borås
Sweden	Forskningsenheten Carlanderska	Göteborg
Sweden	Akademiska sjukhuset	Uppsala
United Kingdom	Waterloo Medical Centre	Blackpool
United Kingdom	Clifton Medical Centre, Rotherham	Rotherham
United States	Washington Center for Weight Management and Research, Inc.	Arlington	Virginia
United States	Velocity Clinical Research, Inc.	Cleveland	Ohio
United States	TLM Medical Services, LLC	Columbia	South Carolina
United States	Valley Weight Loss Clinic	Fargo	North Dakota
United States	L-MARC Research Center	Louisville	Kentucky
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Diablo Clinical Research	Walnut Creek	California
United States	Allegiance Research Specialists	Wauwatosa	Wisconsin
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Germany,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Body Weight From Baseline to Week 46	Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary	Weight Loss of = 5% of Baseline Weight at Week 46	Weight loss of greater than or equal to 5 percent (=5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of =5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Secondary	Weight Loss of = 10% of Baseline Weight at Week 46	Weight loss of greater than or equal to 10 percent (=10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of =10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Secondary	Weight Loss of = 15% of Baseline Weight at Week 46	Weight loss of greater than or equal to 15 percent (=15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of =15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Secondary	Absolute Change in Body Weight From Baseline to Week 46	Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary	Absolute Change in Waist Circumference From Baseline to Week 46	Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
Secondary	Absolute Change in Systolic Blood Pressure From Baseline to Week 46	Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary	Absolute Change in Diastolic Blood Pressure From Baseline to Week 46	Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

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