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

NCT05822544 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • OrsoBio, Inc

    lead INDUSTRY

Principal Investigators

  • OrsoBio Study Director · OrsoBio, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-22
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822544 on ClinicalTrials.gov