Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05822544
PHASE1

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

Sponsor: OrsoBio, Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

564

Start Date

2023-04-22

Completion Date

2026-06

Last Updated

2025-12-18

Healthy Volunteers

Yes

Interventions

DRUG

TLC-6740 Oral Solution

Oral solution of TLC-6740

OTHER

Placebo Oral Solution

Placebo-to-match oral solution TLC-6740

DRUG

TLC-6740 Tablet

Tablet formulation of TLC-6740

DRUG

Drug Metabolizing Enzyme

Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin

DRUG

Tirzepatide

Subcutaneous injection of tirzepatide

OTHER

Placebo Tablet

Placebo-to-match tablet formulation of TLC-6740

Locations (4)

OrsoBio Auckland Research Site 1

Auckland, New Zealand

OrsoBio Auckland Research Site 2

Auckland, New Zealand

OrsoBio Auckland Research Site 3

Auckland, New Zealand

OrsoBio Research Site

Christchurch, New Zealand