A Phase 1/1b Study of Single and Multiple Ascending Doses of TLC 6740 in Healthy Subjects, Including Evaluation of Food Effect and Potential Drug-Drug Interactions, and Preliminary Safety and Efficacy in Subjects With Obesity, With or Without Diabetes

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive (Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Parts F, G)

• Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 (Parts F, G)

• Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min (Parts A-E); eGFR ≥ 60 mL/min/1.73m2 or eGFR ≥ 45 mL/min/1.73m2, depending on cohort (Parts F, G)

• ALT/AST/ALP ≤ 1 x ULN (Parts A-E); ALT/AST \< 3 x ULN, ALP \< 1.5 x ULN (Parts F, G)

• Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance (Parts A-E)

• Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator

• Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission

• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception

• Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs

Locations
Other Locations
New Zealand
OrsoBio Reseach Site
RECRUITING
Auckland
OrsoBio Research Site
RECRUITING
Auckland
OrsoBio Research Site
RECRUITING
Christchurch
Contact Information
Primary
Ryan Huss, MD
Clinicaltrials_Inquires@orsobio.com
650-382-2225
Time Frame
Start Date: 2023-04-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 564
Treatments
Experimental: Oral Solution
Oral solution of TLC-6740
Experimental: Tablet
Tablet formulation of TLC-6740
Experimental: Drug Metabolizing Enzyme
Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin
Experimental: TLC-6740 + Tirzepatide
TLC-6740 tablet + subcutaneous injection of tirzepatide
Experimental: Placebo + Tirzepatide
TLC-6740 placebo + subcutaneous injection of tirzepatide
Related Therapeutic Areas
Sponsors
Leads: OrsoBio, Inc

This content was sourced from clinicaltrials.gov

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