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HypertriglyceridemiaPhase 2NCT06564584

Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD

A Phase 2 study testing TLC-2716 Dose 1 and TLC-2716 Dose 2 in people with Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease, run by OrsoBio, Inc at 4 sites in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
TLC-2716 Dose 1 and TLC-2716 Dose 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
4 sitesMexico
Study dates
12 Aug 2024to Sep 2025
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI ≥ 28 kg/m2 at Screening
  • Fasting TG ≥ 350 mg/dL
  • Subjects without diabetes or subjects with diabetes and HbA1c < 9.5% at Screening
  • Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet count) must fall within the protocol-defined ranges
  • A clinical diagnosis of NAFLD/NASH within 5 years of Screening based on historical hepatic imaging (e.g., ultrasound, MRI, computed tomography [CT], or Controlled Attenuation Parameter [CAP] by vibration-controlled transient elastography ≥ 250 dB/m), and no documented weight loss > 5% between the date of the historical hepatic imaging and Screening OR a historical liver biopsy within 5 years of Screening consistent with NAFLD/NASH without cirrhosis and no documented weight loss > 5% between the date of the historical liver biopsy and Screening
  • Normotensive subjects or subjects without uncontrolled hypertension, defined as systolic blood pressure > 155 mmHg and/or diastolic blood pressure > 90 mmHg at Screening
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  • A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator
  • Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to first dose of study drug
  • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Who cannot join

  • HbA1c ≥ 9.5% at Screening
  • Weight loss > 5% during the 90 days prior to Screening
  • Pregnant or lactating subjects.
  • 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
Show all 20Show fewer
  • Medical history of liver disease other than NAFLD/NASH, 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.
  • Any history of cirrhosis or decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score > 6 at Screening
  • Unstable cardiovascular disease
  • History of intestinal resection or malabsorptive condition that may limit the absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.
  • Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator
  • Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator
  • History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized non-melanoma skin cancer
  • History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator
  • Known hypersensitivity to study drug, its metabolites, or formulation excipients
  • Presence of any medical condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, including a history of substance abuse or a psychiatric disorder, including any subject with a psychiatric hospital admission or emergency room visit in the 2 years prior to Screening
  • Any laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study results
  • Medications or therapies prescribed or taken over-the-counter for weight loss, in the 90 days prior to Screening
  • Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

4 sites in 1 country.

Ryan Huss, MD contact

650-382-2225

Clinicaltrials_Inquires@orsobio.com

Mexico4 sites, 4 recruiting

  • OrsoBio Research Site

    Guadalajara, Jalisco, 45116

    Recruiting

  • OrsoBio Research Site

    Mexico City, Mexico City, 06700

    Recruiting

  • OrsoBio Research Site

    Mexico City, Mexico City, 14080

    Recruiting

  • OrsoBio Research Site

    Zapopan, Jalisco, 45170

    Recruiting

Other trials in Mexico

About this study

Official title: A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease

This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.

Read the detailed description

This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.

Participation in the study can last up to approximately 10 weeks, including a 4 week Screening period, a 4-week treatment period during which study drugs will be administered, and a 2-week follow-up period.

Being tested
TLC-2716 Dose 1, TLC-2716 Dose 2, Placebo
Medical subject headings
Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease

What participants receive

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

  • TLC-2716 Dose 1Drug

    Capsules administered orally

  • TLC-2716 Dose 2Drug

    Capsules administered orally

  • PlaceboDrug

    Capsules administered orally

Study groups in NCT06564584
Study groupRoleWhat they receive
TLC-2716 Dose 1ExperimentalOral dose of TLC-2716 Dose 1
Receives: Drug: TLC-2716 Dose 1
TLC-2716 Dose 2ExperimentalOral dose of TLC-2716 Dose 2
Receives: Drug: TLC-2716 Dose 2
PlaceboPlacebo comparatorOral dose of placebo-to-match
Receives: Drug: Placebo

What is being measured

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

  1. Change in fasting triglycerides

    Relative (%) change in fasting triglycerides at Week 4 from baseline

    Measured: Through study completion, up to Day 28 of the study

  2. Incidence of TLC-2716 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 28 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 posted21 Aug 2024
  2. Study start12 Aug 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionSep 2025 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564584
Sponsor's protocol ID
2716-CL-102
Status last verified
Aug 2024
First submitted
19 Aug 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TLC-2716 Dose 1 and TLC-2716 Dose 2 in people with Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease, run by OrsoBio, Inc at 4 sites in Mexico.

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: status not confirmed, as of the sponsor's last update on 3 Apr 2025. 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 Mexico. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ryan Huss, MD (650-382-2225, Clinicaltrials_Inquires@orsobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fasting triglycerides (time frame: Through study completion, up to Day 28 of the study). The study lists 2 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 NCT06564584.

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 3 Apr 2025.

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