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Healthy SubjectsPhase 1NCT05822544

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

A Phase 1 study testing TLC-6740 Oral Solution, TLC-6740 Tablet and Drug Metabolizing Enzyme in people with Healthy Subjects and Obesity, run by OrsoBio, Inc at 4 sites in New Zealand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Obesity, Type 2 Diabetes
What is being tested?
TLC-6740 Oral Solution, TLC-6740 Tablet and Drug Metabolizing Enzyme
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
564 participants
Where
4 sitesNew Zealand
Study dates
22 Apr 2023to Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

4 sites in 1 country.

New Zealand4 sites

  • OrsoBio Auckland Research Site 1

    Auckland

  • OrsoBio Auckland Research Site 2

    Auckland

  • OrsoBio Auckland Research Site 3

    Auckland

  • OrsoBio Research Site

    Christchurch

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-6740 in healthy subjects and subjects with obesity. The exploratory objective is to evaluate the PD of TLC-6740 in healthy subjects and subjects with obesity, with or without type 2 diabetes. This study is comprised of seven parts: Part A (single-ascending dose), Part B (multiple-ascending dose), Part C (adaptive single- and/or multiple-ascending dose), Part D (relative bioavailability of a tablet formulation of TLC-6740), Part E (drug-drug interaction study to determine the effect of TLC-6740 on drug metabolizing enzymes), Part F (multiple dose of TLC-6740 in subjects with obesity with or without type 2 diabetes mellitus), and Part G (multiple dose of TLC-6740 in subjects with obesity receiving tirzepatide). Up to 48, 50, 100, 8, and 28 healthy subjects will be recruited in Parts A, B, C, D, and E, respectively. Up to 180 and 150 obese subjects will be recruited in Parts F and G, respectively. The effect of food on TLC-6740 PK will also be evaluated in this study.

Being tested
TLC-6740 Oral Solution, Placebo Oral Solution, TLC-6740 Tablet, Drug Metabolizing Enzyme, Tirzepatide
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLC-6740 Oral SolutionDrug

    Oral solution of TLC-6740

  • Placebo Oral SolutionOther

    Placebo-to-match oral solution TLC-6740

  • TLC-6740 TabletDrug

    Tablet formulation of TLC-6740

  • Drug Metabolizing EnzymeDrug

    Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin

  • TirzepatideDrug

    Subcutaneous injection of tirzepatide

  • Placebo TabletOther

    Placebo-to-match tablet formulation of TLC-6740

Study groups in NCT05822544
Study groupRoleWhat they receive
Oral SolutionExperimentalOral solution of TLC-6740
Receives: Drug: TLC-6740 Oral Solution; Other: Placebo Oral Solution
TabletExperimentalTablet formulation of TLC-6740
Receives: Drug: TLC-6740 Tablet; Other: Placebo Tablet
Drug Metabolizing EnzymeExperimentalOral dose of omeprazole, voriconazole, itraconazole, or rifampicin
Receives: Drug: TLC-6740 Tablet; Drug: Drug Metabolizing Enzyme
TLC-6740 + TirzepatideExperimentalTLC-6740 tablet + subcutaneous injection of tirzepatide
Receives: Drug: TLC-6740 Tablet; Drug: Tirzepatide
Placebo + TirzepatideExperimentalTLC-6740 placebo + subcutaneous injection of tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of TLC-6740 treatment-emergent adverse events

    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.

    Measured: 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

  2. PK of TLC-6740 AUC

    Area under the concentration-time curve

    Measured: 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

  3. PK of TLC-6740 Cmax

    Maximum plasma concentration

    Measured: 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

  4. PK of TLC-6740 tmax

    Time to reach Cmax

    Measured: 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

  5. PK of TLC-6740 t1/2

    Half-life

    Measured: 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

  6. PK of TLC-6740 CL/F

    Apparent clearance, calculated as dose/AUC0-inf

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start22 Apr 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This study consists of seven parts: Part A (single-ascending dose), Part B (multiple-ascending dose), Part C (adaptive single- and/or multiple-ascending dose), Part D (relative bioavailability of a tablet formulation of TLC-6740), Part E (drug-drug interaction study to determine the effect of TLC-6740 on drug metabolizing enzymes), Part F (multiple dose of TLC-6740 in subjects with obesity with or without type 2 diabetes mellitus), and Part G (multiple dose of TLC-6740 in subjects with obesity receiving tirzepatide).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
564 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822544
Sponsor's protocol ID
6740-CL-101
Status last verified
Jun 2026
First submitted
7 Apr 2023
Last updated
21 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TLC-6740 Oral Solution, TLC-6740 Tablet and Drug Metabolizing Enzyme in people with Healthy Subjects and Obesity, run by OrsoBio, Inc at 4 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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