None listed
Conditions
Brief summary
A Phase 1b Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple Dose Safety and Tolerability Study of Daily Dosing of BL-001 for 12 Weeks in Adults with Obesity. The study is being conducted to test the safety and tolerability of BL-001 in adult participants living with obesity and to determine the effect of BL-001 on the body by measuring changes in body weight. Adult participants will be randomised into 1 of 3 treatment arms at a ratio of 3:3:2. Eligible participants will complete a 14 day Screening period, undergo a 12-week Treatment period and a follow-up visit at Week 16.
Interventions
This is a Phase 1b randomized, parallel-group, double-blind, placebo controlled study evaluating the safety and tolerability of daily doses of BL-001 for 12 weeks in adult participants with obesity.
Adult participants will be randomised into 1 of 3 treatment arms at a ratio of 3:3:2.
- Arm A Dose 3b (n=18): BL-001 (combination of 2 strains of bacteria consisting of 10 billion colony forming units of A. muciniphilia and 2.5 billion colony forming units of P. merdae)
- Arm B Dose 4b (n=18): BL-001
This is a Phase 1b randomized, parallel-group, double-blind, placebo controlled study evaluating the safety and tolerability of daily doses of BL-001 for 12 weeks in adult participants with obesity. Adult participants will be randomised into 1 of 3 treatment arms at a ratio of 3:3:2. - Arm A Dose 3b (n=18): BL-001 (combination of 2 strains of bacteria consisting of 10 billion colony forming units of A. muciniphilia and 2.5 billion colony forming units of P. merdae) - Arm B Dose 4b (n=18): BL-001 (combination of 2 bacteria consisting of 100 billion colony forming units of A. muciniphilia and 25 billion colony forming units of P. merdae) - Arm C (n=12): Placebo BL-001 is administered as oral capsules and is a live biotherapeutic product. Each dose of the study drug will consist of 3 capsules taken once daily. Eligible participants will complete a 14 day Screening period, undergo a Treatment period until Week 12 and a follow-up visit at Week 16. Participants will be provided a diary to record dates and times of study drug administration and study staff will review the study diary at each clinic visit. Drug capsule return will also be used to monitor compliance.
Sponsors
Bloom Science Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Adult males and females, 18 to 65 years of age - BMI greater than or equal to 30.0 and lesser than or equal to 39.9 kg/m2. - Waist circumference greater than 100 cm (men), greater than 89 cm (women) - Stable body weight within 3 months prior to enrolment - History (prior to the 3 months before enrolment) of at least one self-reported unsuccessful dietary effort to lose body weight - No lifestyle changes including diet and exercise regimen within 3 months prior to enrolment. - Obese but otherwise medically healthy (in the opinion of the study doctor), as determined by pre-study medical history, and without clinically significant abnormalities - The volunteer is a nonsmoker and must be willing to abstain from smoking (including tobacco, e-cigarettes, marijuana, cannabidiol, or other drugs) for the duration of the study - The volunteer must be willing to abstain from consuming alcohol for the duration of the study
Exclusion criteria
- Known hypersensitivity to the study drug or any of the study drug ingredients - Abnormal bowel movements (3 or more stools per day, or less than 3 stools per week) - History of anaphylaxis or other significant allergy which, in the opinion of the study doctor, would interfere with the volunteer’s ability to participate in the study - History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within 3 months prior to enrolment determined by the study doctor to be clinically relevant - Abnormal dietary habits or substantial changes in eating habits as determined by the study doctor within 4 weeks prior to enrolment - Diagnosis of diabetes Type 1 diabetes mellitus or Type 2 diabetes mellitus - Previous or planned (during the study) treatment for obesity with surgery or a weight loss device, or prior surgery or modification of the gastrointestinal tract that in the study doctor’s opinion could interfere with body weight - History of surgery or hospitalization within 3 months prior to enrolment, or surgery planned during the study. - Any history of malignant disease in the last 10 years - Poorly controlled hypertension - Any other condition, prior or concomitant therapy that in the opinion of the study doctor would make the volunteer unsuitable for this study
Outcome results
None listed