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 combination therapy of BC-006 and tirzepatide (TZP), both
Sponsors
BaseCure Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 65 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 electrocardiogram (ECG) that, in the opinion of the investigator, would affect participant safety. 3. Body mass index (BMI) of =30 to <50 kg/m2 4. Fibrosis-4 (Fib-4) score =1.4 5. At least one additional obesity related complication (ORC) such as hypertension, hyperlipidemia, metabolic dysfunction-associated steatotic liver disease or stable cardiovascular disease, with the exception of Type 2 diabetes mellitus. Medications to treat ORC must be unchanged for 30 days prior to screening. 6. Self-reported stable body weight (±5%) for at least 3 months prior to screening. 7. Female participants must not be pregnant or lactating and must be willing to comply with protocol contraceptive requirements until EOT 8. Male participants must be willing to comply with protocol contraceptive requirements and agree to abstain from sperm or egg donation until EOT (Day 337). 9. Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Exclusion criteria: 1. Clinically significant infection, 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 trial, or which would, in the opinion of the investigator, unacceptably increase the participant’s risk to participate in the trial. 2. Diagnosed with diabetes (Type 1, 2 or other forms of diabetes mellitus, excluding a history of gestational diabetes and prediabetic participants with glycated hemoglobin [HbA1c] =6.5%). 3. Participants with any of the following: a. Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) >5 × upper limit of normal (ULN) b. Alkaline Phosphatase (ALP) >2 × ULN. c. Total serum bilirubin >1.5 × ULN except participants with Gilbert’s syndrome at screening who are permitted if all other criteria are met d. Platelet count 1.3 in the absence of anticoagulants. f. Albumin 160 mmHg at screening, confirmed by repeat. 9. Sitting or semi-supine (for at least 5 minutes) diastolic blood pressure >100 mmHg at screening, confirmed by repeat. 10. Presence of birthmarks, tattoos, wounds, scars, blemishes, heavy hair, or other skin conditions (such as eczema) at the planned dosing site/s that could be expected to obscure the observation of injection site reactions. 11. Use of antibiotics or immunosuppressive medications such as systemic steroids within 30 days prior to BC-006 dosing on Day 1. 12. Use of any medications including GLP-1 medications, OTC medications or herbal therapies for the short-term or chronic treatment of obesity within 3 months of screening. 13. Use of any anti-diabetic medications within 30 days of screening, or 90 days for GLP-1 medications. 14. Smoking >5 cigarettes per day (or nicotine equivalent) within 30 days prior to screening or anticipated use during the trial, and unable to abstain completely from smoking/vaping during the inpatient stay. 15. Any vaccination within 14 days prior to screening or anticipated live vaccination while participating in the trial. 16. Receipt of an investigational product or device, or participation in a drug research trial, within a period of 60 days (or 5 half-lives of the drug, whichever is longer) or within 2 years from previous siRNA therapy before dosing on Day 1. 17. Prior exposure to BC-006 at any time in the past. 18. Positive screen for hepatitis B surface antigen (HbsAg), hepatitis C antibody (if positive, amplification may be performed to confirm; cured hepatitis C can be enrolled), or human immunodeficiency virus (HIV) antibody. 19. Positive alcohol breath test
Countries
New Zealand
Contacts
Public ContactYvonne Chen
Outcome results
None listed