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Tests treatment safety and results for Hypertriglyceridemia
Official title Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
ClinicalTrials.gov ID: NCT06564584
What this study is testing
What is TLC-2716 Dose 1?
TLC-2716 Dose 1 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hypertriglyceridemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- BMI ≥ 28 kg/m2 at Screening
- Fasting TG ≥ 350 mg/dL
- people without diabetes or people 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]...
You likely can't join if
- HbA1c ≥ 9.5% at Screening
- Weight loss \> 5% during the 90 days prior to Screening
- Pregnant or lactating people.
- 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
See the full eligibility criteria
- BMI ≥ 28 kg/m2 at Screening
- Fasting TG ≥ 350 mg/dL
- people without diabetes or people 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...
- Normotensive people or people without uncontrolled hypertension, defined as systolic blood pressure \> 155 mmHg and/or diastolic blood pressure \> 90 mmHg at Screening
- A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator
- Female people 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 people of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- HbA1c ≥ 9.5% at Screening
- Weight loss \> 5% during the 90 days prior to Screening
- Pregnant or lactating people.
- 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 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...
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Guadalajara, Jalisco, Mexico
- Zapopan, Jalisco, Mexico
- Mexico City, Mexico City, Mexico
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guadalajara, Jalisco, Mexico; Zapopan, Jalisco, Mexico; Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.