RecruitingPhase 1NCT05822544

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

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


Sponsor

OrsoBio, Inc

Enrollment

564 participants

Start Date

Apr 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This phase 1 study tests TLC-6740, a new experimental drug, for the first time in humans. The study first assesses safety in healthy volunteers, then tests it in people with obesity with or without diabetes. The drug is being developed as a potential new treatment for obesity and diabetes-related conditions. **You may be eligible if...** - You are a healthy non-smoker between 18 and 55 years old with a BMI of 19–35 (for healthy volunteer part) - OR you are between 18 and 70 with a BMI of 30 or higher and have obesity with or without type 2 diabetes (for the obesity/diabetes part) - Your kidney function, liver enzymes, and blood tests are within acceptable ranges **You may NOT be eligible if...** - You are a smoker or have recently quit - You have significant heart, liver, or kidney disease - You have type 1 diabetes - You are pregnant or breastfeeding - You have taken other investigational drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTLC-6740 Oral Solution

Oral solution of TLC-6740

OTHERPlacebo Oral Solution

Placebo-to-match oral solution TLC-6740

DRUGTLC-6740 Tablet

Tablet formulation of TLC-6740

DRUGDrug Metabolizing Enzyme

Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin

DRUGTirzepatide

Subcutaneous injection of tirzepatide

OTHERPlacebo 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

View Full Details on ClinicalTrials.gov

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NCT05822544


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