Healthy SubjectsPhase 1NCT05483998
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
A Phase 1 study testing TLC-2716 in people with Healthy Subjects, run by OrsoBio, Inc at 1 site in New Zealand.
Trial summary
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TLC-2716
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Sep 2022to 18 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive
- Body mass index from 19 to 35 kg/m2, inclusive
- Estimated glomerular filtration rate ≥ 80 mL/min
- Normal liver biochemistry tests
- 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
- Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
Show all 9Show fewer
- 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
- Subjects with triglycerides ≥ 500 mg/dL
- Subjects with low-density lipoprotein ≥ 190 mg/dL
- 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
Show all 20Show fewer
- 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
- Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen (paracetamol), ibuprofen, and/or hormonal contraceptive medications
- Subjects who have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
- Medical history of serious skin disease in the opinion of the investigator, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
- 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
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-2716 in Healthy Subjects
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
Read the detailed description
This study is a randomized, placebo-controlled, sponsor-unblinded, and comprised of three parts: Part A (single-ascending dose), Part B (multiple-ascending dose), and Part C (adaptive single- and/or multiple-ascending dose).
- Conditions
- Healthy Subjects
- Being tested
- TLC-2716, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC-2716Drug
TLC-2716
PlaceboOther
Placebo to match
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Part A will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive a single oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level). Receives: Drug: TLC-2716; Other: Placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Part B will be comprised of up to 50 healthy participants over 5 cohorts of 10. Each participant will receive 14 oral doses of TLC-2716 or placebo over 14 days (given once daily) at different dose levels (1 cohort per dose level). Receives: Drug: TLC-2716; Other: Placebo |
| Part C: Adaptive SAD and/or MAD | Experimental | Part C is an adaptive style where the dosing level is a single- or multiple-ascending dose design. Based on safety and pharmacokinetic data from Parts A and B, doses for Part C will be chosen. Part C will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive an oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level). Receives: Drug: TLC-2716; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-emergent adverse events (TEAEs) in single ascending dose (SAD) compared to placebo
TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
Measured: Up to Day 15
Number of subjects with clinically significant change from Baseline in vital signs in SAD
Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
Measured: Day 1-Day 4, and Follow-up (after 11 days)
Number of subjects with laboratory abnormalities in SAD
Hematology and serum chemistry.
Measured: Up to 15 days
Number of subjects with electrocardiogram (ECG) abnormalities in SAD
12-lead ECG.
Measured: Up to 15 days
Number of subjects with TEAEs in multiple ascending dose (MAD) compared to placebo
TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
Measured: Up to Day 28
Number of subjects with clinically significant change from Baseline in vital signs in MAD
Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
Measured: Day 1 - Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, and Follow-up (after 11 days)
Number of subjects with laboratory abnormalities in MAD
Hematology and serum chemistry.
Measured: Up to 28 days
Number of subjects with ECG abnormalities in MAD
12-lead ECG
Measured: Up to 28 days
Secondary outcomes (20)
Plasma concentration of each dose of study drug to determine AUClast in SAD
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine AUCinf in SAD
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine %AUCexp in SAD
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine CL/F in SAD
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Cmax in SAD
Cmax is defined as the maximum concentration of drug.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Tmax in SAD
Tmax is defined as the time (observed time point) of Cmax.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Clast in SAD
Clast is defined as the last observable concentration of drug.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Tlast in SAD
Tlast is defined as the time (observed time point) of Clast.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine t1/2 in SAD
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine λz in SAD
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
Measured: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine AUClast in MAD
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine AUCtau in MAD
AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Ctau in MAD
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine CLss/F in MAD
CLss/F is the total body clearance for extravascular administration divided by the fraction of dose absorbed.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Cmax in MAD
Cmax is defined as the maximum concentration of drug.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Tmax in MAD
Tmax is defined as the time (observed time point) of Cmax.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Clast in MAD
Clast is defined as the last observable concentration of drug.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Tlast in MAD
Tlast is defined as the time (observed time point) of Clast.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine t1/2 in MAD
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine λz in MAD
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
Measured: Day 1, Day 3, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start9 Sep 2022
- Primary completion13 Apr 2023
- Study completion18 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrsoBio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- OrsoBio Study Director, Study director, OrsoBio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483998
- Sponsor's protocol ID
- 2716-CL-101
- Status last verified
- May 2024
- First submitted
- 27 Jul 2022
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Benegiamo G, Vijayakumar A, Sroda N, Kimura M, Huss RS, Weng S, Murakami E, Kirby BJ, von Alvensleben GVG, Kremoser C, Gane EJ, Takebe T, Myers RP, Subramanian GM, Auwerx J. An oral, liver-restricted LXR inverse agonist for dyslipidemia: preclinical development and phase 1 trial. Nat Med. 2026 Mar;32(3):883-893. doi: 10.1038/s41591-025-04169-6. Epub 2026 Jan 16.
PubMed 41545590
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-2716 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05483998
- Acronym / sponsor ID
- 2716-CL-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OrsoBio, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
Detailed description
This study is a randomized, placebo-controlled, sponsor-unblinded, and comprised of three parts: Part A (single-ascending dose), Part B (multiple-ascending dose), and Part C (adaptive single- and/or multiple-ascending dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: TLC-2716, Other: PlaceboPart A will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive a single oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level). |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: TLC-2716, Other: PlaceboPart B will be comprised of up to 50 healthy participants over 5 cohorts of 10. Each participant will receive 14 oral doses of TLC-2716 or placebo over 14 days (given once daily) at different dose levels (1 cohort per dose level). |
| Part C: Adaptive SAD and/or MAD | Experimental | Drug: TLC-2716, Other: PlaceboPart C is an adaptive style where the dosing level is a single- or multiple-ascending dose design. Based on safety and pharmacokinetic data from Parts A and B, doses for Part C will be chosen. Part C will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive an oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive
- Body mass index from 19 to 35 kg/m2, inclusive
- Estimated glomerular filtration rate ≥ 80 mL/min
- Normal liver biochemistry tests
- 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
Key exclusion criteria (20 listed)
- Pregnant or lactating subjects
- Subjects with triglycerides ≥ 500 mg/dL
- Subjects with low-density lipoprotein ≥ 190 mg/dL
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC-2716TLC-2716 | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Adaptive SAD and/or MAD |
| PlaceboPlacebo to match | Other | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Adaptive SAD and/or MAD |
Primary outcome
Number of subjects with treatment-emergent adverse events (TEAEs) in single ascending dose (SAD) compared to placebo
Time frame: Up to Day 15
TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
Number of subjects with clinically significant change from Baseline in vital signs in SAD
Time frame: Day 1-Day 4, and Follow-up (after 11 days)
Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
Number of subjects with laboratory abnormalities in SAD
Time frame: Up to 15 days
Hematology and serum chemistry.
Number of subjects with electrocardiogram (ECG) abnormalities in SAD
Time frame: Up to 15 days
12-lead ECG.
Number of subjects with TEAEs in multiple ascending dose (MAD) compared to placebo
Time frame: Up to Day 28
TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
Number of subjects with clinically significant change from Baseline in vital signs in MAD
Time frame: Day 1 - Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, and Follow-up (after 11 days)
Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
Number of subjects with laboratory abnormalities in MAD
Time frame: Up to 28 days
Hematology and serum chemistry.
Number of subjects with ECG abnormalities in MAD
Time frame: Up to 28 days
12-lead ECG
20 secondary outcomes
Plasma concentration of each dose of study drug to determine AUClast in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine AUCinf in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine %AUCexp in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine CL/F in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Cmax in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Tmax in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Clast in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine Tlast in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine t1/2 in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine λz in SAD
Time frame: Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
Plasma concentration of each dose of study drug to determine AUClast in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine AUCtau in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Ctau in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine CLss/F in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Cmax in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Tmax in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Clast in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine Tlast in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine t1/2 in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Plasma concentration of each dose of study drug to determine λz in MAD
Time frame: Day 1, Day 3, Day 7, Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 41545590Li X, Benegiamo G, Vijayakumar A, Sroda N, Kimura M, Huss RS, Weng S, Murakami E, Kirby BJ, von Alvensleben GVG, Kremoser C, Gane EJ, Takebe T, Myers RP, Subramanian GM, Auwerx J. An oral, liver-restricted LXR inverse agonist for dyslipidemia: preclinical development and phase 1 trial. Nat Med. 2026 Mar;32(3):883-893. doi: 10.1038/s41591-025-04169-6. Epub 2026 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OrsoBio Study Director study director
OrsoBio, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLC-2716 in people with Healthy Subjects, run by OrsoBio, Inc at 1 site 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: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with treatment-emergent adverse events (TEAEs) in single ascending dose (SAD) compared to placebo (time frame: Up to Day 15). The study lists 8 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 NCT05483998, which also lists 1 linked publication.
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 20 May 2024.