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Clinical Trial Details

Trial ID: L2699
Source ID: NCT05822544
Associated Drug: Tlc-6740 Oral Solution
Title: Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects with Obesity, with or Without Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
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
Outcome Measures: Primary: Incidence of TLC-6740 treatment-emergent adverse events, Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related., Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study|PK of TLC-6740 AUC, Area under the concentration-time curve, Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study|PK of TLC-6740 Cmax, Maximum plasma concentration, Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study|PK of TLC-6740 tmax, Time to reach 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 87 (Parts F, G) of the study|PK of TLC-6740 t1/2, Half-life, Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study|PK of TLC-6740 CL/F, Apparent clearance, calculated as dose/AUC0-inf, Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study |
Sponsor/Collaborators: Sponsor: OrsoBio, Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 506
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-22
Completion Date: 2025-08
Results First Posted:
Last Update Posted: 2025-02-12
Locations: OrsoBio Reseach Site, Auckland, New Zealand|OrsoBio Research Site, Auckland, New Zealand|OrsoBio Research Site, Christchurch, New Zealand
URL: https://clinicaltrials.gov/show/NCT05822544