The overall purpose of this trial is to assess the efficacy on weight loss and maintenance, and tolerability of four different doses of BI 456906 compared to placebo in patients with obesity or overweight (BMI >= 27kg/m2), without type 1 or type…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage change in body weight (%) from baseline to week 46
Secondary outcome
Secondary endpoints are:
- Weight loss of >= 5% of baseline weight at week 46
- Weight loss of >= 10% of baseline weight at week 46
- Weight loss of >= 15% of baseline weight at week 46
- Absolute change in body weight (kg) from baseline to week 46
- Absolute change in waist circumference (cm) from baseline to week 46
- Absolute change in systolic blood pressure (mmHg) from baseline to week 46
- Absolute change in diastolic blood pressure (mmHg) from baseline to week 46
Background summary
Obesity is a chronic, complex, heterogeneous disease caused by a disruption of
homeostatic control of body weight and a failure to
maintain constant body fat mass.
To help patients with obesity targeting of multiple signaling pathways
(including CNS and peripheral organs) is probably necessary to achieve more
significant improvements in weight management and might reverse the progression
of these metabolic disorders and related comorbidities.
Currently, there are four major FDA-approved medications for chronic weight
management, however those medications only provide modest
reduction of body weight. BI 456906 is a dual agonist of GLP-1 and Glucagon
receptors, targeting both GLP-1 and
Glucagon signalling pathways BI 456906 is expected to provide synergistic
clinical benefit for chronic weight management and obesity.
Study objective
The overall purpose of this trial is to assess the efficacy on weight loss and
maintenance, and tolerability of four different doses of BI 456906 compared to
placebo in patients with obesity or overweight (BMI >= 27kg/m2), without type 1
or type 2 diabetes, in order to characterize the dose-response relationship
within the therapeutic range, and to select the target dose(s) for phase III
clinical development.
Study design
This is a 46 week randomised, double-blind, parallel-design,
placebo-controlled, multinational and multi-centre study with 4 different
maintenance doses (ranging from 0.6mg/week to 4.8mg/week) in patients with
obesity or overweight (BMI >= 27kg/m2), and without diabetes.
All patients (including placebo) will receive counselling for a reduced-calorie
diet with an energy deficit of approximately 500 kcal/day, as well as increased
physical activity counselling (recommended minimum 150 minutes/week) on a
monthly basis.
There will be a screening period of minimum one week (time needed to obtain all
examination results), that could be extended up to 12 weeks. The treatment
duration is 46 weeks in total including a dose escalation phase of 20 weeks to
minimize GI side effects of BI 456906. This is followed by a 26-week
maintenance phase, and a 3-week (4 weeks after last dose) follow-up period.
Intervention
Participants will be randomly assigned to one of the 4 active dose arms of BI
456906 or placebo at a 1:1:1:1:1 ratio.
The different treatment arms and the dose escalation scheme are presented in
Table 4.1.4:1 of the protocol.
Study burden and risks
Burden for the subject:
- The subject will need to regularly visit the research center as part of the
study (20 visits for approximately one year)
- The subject receive a diet and exercise program during the study
- Several questionnaires are to be completed:
* on suicidal thoughts (C-SSRC), depression/ psychiatric disorders (PHQ-9): 17x
* to assess eating behavior (TFEQ-R18v2, PGI and BI-eating behavior): 4x
* to assess daily activity (SF-36v2 (PF10) and PGI): 4x
- Complete a 3-day food diary: 3x
- Record on a paper diary the daily food intake and on an electronic diary:
weekly injections, weight measurements and physical activity
- Other assessments include: blood sampling (18x), pregnancy test (14x),
physical examination (15x), including heart rate and blood pressure meeting and
ECG
- Females should use two forms of effective contraception
Risks:
- There is no identified risk for BI 456906, based on the toxicology programme
or any clinical trials conducted for this product to date.
- The risk for patients caused by participation in the trial, including the
study procedures and exposure to the study drug, are reasonably low
- The expected side effects are known to be temporary, dose dependent, easy to
monitor and manageable in clinical trials.
Benefit:
Subjects treated with BI 456906 are expected to achieve improved weight
management results compared to prior to their trial participation.
Comeniusstraat 6
Alkmaar 1817MS
NL
Comeniusstraat 6
Alkmaar 1817MS
NL
Listed location countries
Age
Inclusion criteria
1. Adult >= 18 years and < 75 years of age at screening
2. Written informed consent
3. Obesity or Overweight defined as BMI >=27 kg/m2 at screening
4. A minimum absolute body weight of 70 kg for females and 80 kg for males at
screening
5. Male or female participants. Women of childbearing potential must be willing
and able to use two forms of effective contraception
6. Patients must have undergone at least one previous unsuccessful nonsurgical
weight-loss attempt per investigator*s judgement
Exclusion criteria
1. 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.
2. Obesity induced by an endocrinologic disorder (e.g. Cushing Syndrome)
3. A HbA1c >= 6.5% at screening or diagnosed with type 1 or type 2 diabetes
mellitus
4. Exposure to GLP-1Ra based therapies within three months prior to screening
Further criteria apply.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002479-37-NL |
| ClinicalTrials.gov | NCT04667377 |
| CCMO | NL75490.100.20 |