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

Sponsor
OrsoBio, Inc
Study ID
NCT05822544
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • TLC-6740 Oral Solution — DRUG
    Oral solution of TLC-6740
  • Placebo Oral Solution — OTHER
    Placebo-to-match oral solution TLC-6740
  • TLC-6740 Tablet — DRUG
    Tablet formulation of TLC-6740
  • Drug Metabolizing Enzyme — DRUG
    Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin
  • Tirzepatide — DRUG
    Subcutaneous injection of tirzepatide
  • Placebo Tablet — OTHER
    Placebo-to-match tablet formulation of TLC-6740

Study Details

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.

Key Dates

Start date
Apr 22, 2023
Status verified
May 2025
Primary completion
Feb 28, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
564 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of TLC-6740 treatment-emergent adverse events [ Time Frame: 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 ]

Central Contacts

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