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

Registration

Registration

NCT05822544

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

ACTIVE_NOT_RECRUITING

Enrollment

564

Start

2023-04-22

Primary completion

2026-09

Lead sponsor

OrsoBio, Inc

Conditions

Healthy Subjects; Obesity; Type 2 Diabetes

Interventions

DRUG:TLC-6740 Oral Solution; OTHER:Placebo Oral Solution; DRUG:TLC-6740 Tablet; DRUG:Drug Metabolizing Enzyme; DRUG:Tirzepatide; OTHER:Placebo Tablet

Results posted

FALSE

Registered primary outcomes

• Incidence of TLC-6740 treatment-emergent adverse events [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]
• PK of TLC-6740 AUC [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]
• PK of TLC-6740 Cmax [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]
• PK of TLC-6740 tmax [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]
• PK of TLC-6740 t1/2 [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]
• PK of TLC-6740 CL/F [Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study]