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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
25/03/2025

Titles & IDs
Public title
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects with Obesity, with or Without Diabetes
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
Secondary ID [1] 0 0
6740-CL-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Obesity 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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, or itraconazole

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, or itraconazole

Treatment: Drugs: Tirzepatide
Subcutaneous injection of tirzepatide

Other interventions: Placebo Tablet
Placebo-to-match tablet formulation of TLC-6740
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of TLC-6740 treatment-emergent adverse events
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study
Primary outcome [2] 0 0
PK of TLC-6740 AUC
Assessment method [2] 0 0
Area under the concentration-time curve
Timepoint [2] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study
Primary outcome [3] 0 0
PK of TLC-6740 Cmax
Assessment method [3] 0 0
Maximum plasma concentration
Timepoint [3] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study
Primary outcome [4] 0 0
PK of TLC-6740 tmax
Assessment method [4] 0 0
Time to reach Cmax
Timepoint [4] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study
Primary outcome [5] 0 0
PK of TLC-6740 t1/2
Assessment method [5] 0 0
Half-life
Timepoint [5] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study
Primary outcome [6] 0 0
PK of TLC-6740 CL/F
Assessment method [6] 0 0
Apparent clearance, calculated as dose/AUC0-inf
Timepoint [6] 0 0
Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Parts F, G) of the study

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
506
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OrsoBio, Inc
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
OrsoBio Study Director
Address 0 0
OrsoBio, Inc
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ryan Huss, MD
Address 0 0
Country 0 0
Phone 0 0
650-382-2225
Email 0 0
Clinicaltrials_Inquires@orsobio.com
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