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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05822544
Registration number
NCT05822544
Ethics application status
Date submitted
7/04/2023
Date registered
20/04/2023
Date last updated
23/05/2025
Titles & IDs
Public title
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
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Scientific 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
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Secondary ID [1]
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6740-CL-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects
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Obesity
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Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TLC-6740 Oral Solution
Other interventions - Placebo Oral Solution
Treatment: Drugs - TLC-6740 Tablet
Treatment: Drugs - Drug Metabolizing Enzyme
Treatment: Drugs - Tirzepatide
Other interventions - Placebo Tablet
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
Treatment: Drugs: TLC-6740 Oral Solution
Oral solution of TLC-6740
Other interventions: Placebo Oral Solution
Placebo-to-match oral solution TLC-6740
Treatment: Drugs: TLC-6740 Tablet
Tablet formulation of TLC-6740
Treatment: Drugs: Drug Metabolizing Enzyme
Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin
Treatment: Drugs: Tirzepatide
Subcutaneous injection of tirzepatide
Other interventions: Placebo Tablet
Placebo-to-match tablet formulation of TLC-6740
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of TLC-6740 treatment-emergent adverse events
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Primary outcome [2]
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PK of TLC-6740 AUC
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Assessment method [2]
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Area under the concentration-time curve
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Timepoint [2]
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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
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Primary outcome [3]
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PK of TLC-6740 Cmax
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Assessment method [3]
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Maximum plasma concentration
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Timepoint [3]
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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
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Primary outcome [4]
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PK of TLC-6740 tmax
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Assessment method [4]
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Time to reach Cmax
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Timepoint [4]
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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
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Primary outcome [5]
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PK of TLC-6740 t1/2
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Assessment method [5]
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Half-life
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Timepoint [5]
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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
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Primary outcome [6]
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PK of TLC-6740 CL/F
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Assessment method [6]
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Apparent clearance, calculated as dose/AUC0-inf
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Timepoint [6]
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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
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Eligibility
Key inclusion criteria
* Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive (Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Parts F, G)
* Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI = 30 kg/m2 and = 50 kg/m2 (Parts F, G)
* Estimated glomerular filtration rate (eGFR) = 80 mL/min (Parts A-E); eGFR = 60 mL/min/1.73m2 or eGFR = 45 mL/min/1.73m2, depending on cohort (Parts F, G)
* ALT/AST/ALP = 1 x ULN (Parts A-E); ALT/AST < 3 x ULN, ALP < 1.5 x ULN (Parts F, G)
* Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance (Parts A-E)
* Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
* Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission
* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Pregnant or lactating subjects
* Unstable type 2 diabetes (as defined as: HbA1c > 10.0%; treatment with insulin and/or pioglitazone within 90 days prior to Screening; any history of diabetic ketoacidosis, hyperosmolar state, and/or acutely decompensated blood glucose control; hypoglycemia unawareness, hospitalization due to hypoglycemia, or history of severe hypoglycemia [requiring outside assistance to regain normal neurologic status]) (Part F)
* History of type 2 diabetes diagnosed prior
* Medical history of type 1 diabetes or latent autoimmune diabetes of adults (LADA)
* Obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide (Part G)
* Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol
* Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing
* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody
* Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
* Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and/or clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction < 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
* Syncope, palpitations, or unexplained dizziness
* Implanted defibrillator or pacemaker
* Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency)
* Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions
* History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery)
* Subjects who have received vaccination for COVID-19 within 14 days of Admission
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
514
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
OrsoBio, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05822544
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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OrsoBio Study Director
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Address
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OrsoBio, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ryan Huss, MD
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Address
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Country
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Phone
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650-382-2225
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Fax
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Email
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Clinicaltrials_Inquires@orsobio.com
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05822544
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