Obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a Phase IIa, randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, PK, PD, and efficacy of BC-006 administered via subcutaneous injection (SC) in ad
Sponsors
BaseCure Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 70 years, inclusive, at the time of signing the informed consent 2. No clinically relevant abnormalities based on medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology, serum chemistry, coagulation, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety 3. Body mass index (BMI) of = 30 to < 45 kg/m2 at Screening 4. At least one additional obesity related complication (ORC) such as hypertension, hyperlipidemia, or stable cardiovascular disease. Medications to treat ORC must be unchanged for 30 days prior to Screening 5. Self-reported stable body weight (± 5%) for at least 3 months prior to Screening 6. Male participants must be willing to comply with protocol contraceptive requirements and agree to abstain from sperm donation for at least 6 months after last dose of IP 7. Female participants must not be pregnant or lactating and must be willing to comply with protocol contraceptive requirements until EOT 8. Agree to abstain from sperm or egg donation through 6 months after last dose of IP 9. Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria
Exclusion criteria: 1. Clinically significant infection and/or cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject’s risk if he/she were to participate in the study 2. Diagnosed with type 1, type 2, or other autoimmune form of diabetes or clinical evidence of diabetes (for example hemoglobin A1c = 6.5 percent, fasting blood glucose = 126 mg/dL \[7.0 mmol/L] at screening, non-fasting glucose = 200 mg/dL \[11.1 mmol/L] at screening, or use of any hypoglycemic drugs during screening or within 3 months prior to screening) 3. Subjects with any of the following 3.1. Transaminases (alanine aminotransferase, aspartate aminotransferase) greater than 3 × upper limit of normal (ULN) 3.2. Alkaline phosphatase (ALP) greater than 2 × ULN 3.3. Total serum bilirubin greater than 1.5 × ULN except subjects with Gilbert’s syndrome at screening who are permitted if all other criteria are met 3.4. Platelet count less than 100,000/mm3 3.5. International normalized ratio (INR) greater than 1.3 in the absence of anticoagulants 3.6. Albumin less than 3.5 g/dL (subjects with abnormal but not clinically significant labs may be enrolled after input from the Medical Monitor) 4. History of moderate or more advanced renal disease at any time in the past or abnormal kidney function tests at screening (glomerular filtration rate less than 60 mL/min/1.73 m2 as estimated using the CKD-EPI 2021 equation) 5. Clinically significant allergy to any type of drug at the discretion of the Investigator, or allergy to any constituents of BC-006 Injection; history of anaphylaxis or hospitalization due to drug reaction 6. Any of the following abnormalities on triplicate 12-lead ECG at screening 6.1. PR interval = 210 msec 6.2. QRS complex = 120 msec 6.3. Fridericia’s corrected QT interval (QTcF) greater than 450 msec (males) and greater than 470 msec (females) 6.4. Any clinically significant abnormality on an ECG at the Investigator’s discretion 7. Sitting or semi-supine systolic blood pressure greater than 145 mmHg at screening, confirmed by repeat (up to 2 repeat attempts); systolic blood pressure between 145 and 165 mmHg may be allowed if considered stable and not clinically significant per Investigator judgement 8. Sitting or semi-supine diastolic blood pressure greater than 95 mmHg at screening, confirmed by repeat (up to 2 repeat attempts); diastolic blood pressure between 90 and 105 mmHg may be allowed if considered stable and not clinically significant per Investigator judgement 9. Presence of birthmarks, tattoos, wounds, scars, blemishes, heavy hair, or other skin conditions at the planned dosing sites that could obscure observation of injection site reactions 10. Use of systemic antibiotics or immune suppressive medications within 30 days prior to investigational product dosing on Day 1; short-term corticosteroid use (less than 30 days) is allowed 11. Use of any prescription or over-the-counter medications or supplements for short-term or chronic treatment of obesity within 3 months prior to screening 12. Any vaccination within 14 days prior to screening or anticipated live vaccination while participating in the study 13. Receipt of an investigational product
Countries
Australia
Contacts
Public ContactYvonne Chen
Outcome results
None listed