Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH

Completed · Phase 2 · Has a placebo group

Conditions studied: NON-ALCOHOLIC STEATOHEPATITIS

In brief

A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).

Key facts

Study ID

NCT06054815

Run by

NeuroBo Pharmaceuticals Inc.

People needed

109

Starts

2023-09-14

Expected to finish

2024-10-30

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are able to understand and sign informed consent before the conduct of any protocol specific screening procedures.
• Subjects who are male or female, aged 18 to 75 years inclusive at the time of consent.
• Female subjects of childbearing potential:
• Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last dose of study drug.
• Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last dose of the study drug:
• True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable).
• Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
• Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
• Bilateral tubal occlusion/ligation.
• Intrauterine device (IUD).
• Intrauterine hormone releasing system (IUS).
• Vasectomized partner.
• Female subjects of non-childbearing potential do not need to use birth control during or after study drug treatment if considered of non-childbearing potential due to any of the following criteria:
• Premenopausal female with permanent sterility or permanent infertility as due to one of the following:
• Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
• Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; Investigator discretion should be applied to determining study entry for these individuals.
• Postmenopausal female subjects, with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level ≥ 40 IU/L.
• Male subjects who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male subject has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last dose of the study drug.
• Subjects with a BMI > 23 kg/m2 at first Screening Period visit.
• Subjects with a qualifying ALT result (40 IU/L ≤ ALT < 200 IU/L) as determined by the laboratory assessment at the first Screening Period visit.
• Subjects with a confirmed NASH diagnosis or conditions consistent with NASH.
• Subjects with an HbA1c ≥ 5.7% and < 9.5% (5.7% ≤ HbA1c < 9.5%).
• Subjects with ≥ 8% hepatic fat on MRI after confirming a qualifying ALT result at Screening.
• Subjects with CAP score by FibroScan® of ≥ 290 dB/m at the time of the first Screening Period visit.
• Subjects with 7 kPa ≤ VCTE score by FibroScan® < 14 kPa at the time of the first Screening Period visit.

You may not qualify if…

• Subjects who have used an investigational agent within 30 days or 5 elimination half-lives; whichever is longer prior to the first Screening Period visit.
• Subjects diagnosed with liver disease other than NASH (eg, chronic viral hepatitis, decompensated cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, primary biliary cholangitis, drug-induced liver disease).
• Subjects who have a positive test result for hepatitis A virus immunoglobulin M, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or reactive human immunodeficiency virus (HIV) after providing a qualifying ALT result at the first Screening Period visit, or who have a known history of HIV infection. However, subjects with a positive hepatitis C virus antibody could be eligible after undergoing reflex testing (HCV-RNA negative) and evaluation by the Investigator.
• Clinically significant laboratory results as evaluated by the Investigator after providing a qualifying ALT result at the first Screening Period visit. Subjects will be excluded if:
• AST ≥ 200 U/L
• Platelets ≤ 150,000/mm3
• Albumin < 3.8 g/dL
• Total bilirubin ≥ 1.5 mg/dl, except with clinical diagnosis of Gilbert's syndrome
• Direct bilirubin > 0.3 mg/dL
• Phosphatidylethanol > 40 ng/mL
• INR > 1.3 in the absence of anticoagulants
• Subjects with an estimated glomerular filtration rate < 60 mL/min/1.73m2 based on modification of Diet in Renal Disease (MDRD) formula.
• Subjects with a corrected QT interval by Fridericia (QTcF) of > 450 ms in males, and > 470 ms in females.
• Subjects who are taking one or more of the following medications:
• Within 12 weeks prior to the first Screening Period visit: i. Medication that is known to cause or worsen fatty liver disease (amiodarone, valproate, tamoxifen, methotrexate, etc.) for > 14 days. ii. Medication for weight loss. iii. Chronic use of systemic corticosteroids for > 14 days; however, administration of intranasal, topical, or inhaled corticosteroids is allowed. iv. DPP-4 inhibitors, thiazolidinediones (TZDs), or GLP-1 agonists.
• St. John's Wort or consuming grapefruit juice within 2 weeks prior to the first Screening Period visit.
• Digoxin, strong CYP3A4 inhibitors (a ≥ 10-fold increase in AUC of sensitive substrate), or strong CYP3A4 inducers (decreases the AUC of sensitive index substrates of a given metabolic pathway ≥ 80% increase) received within 5 half-lives or 14 days (whichever is longer) prior to the first Screening Period visit.
• Subjects who cannot get an MRI scan.
• Subjects who have a history of cirrhosis, a VCTE ≥ 14 kPa, portal hypertension as evidenced by a history of splenomegaly > 15 cm, ascites, hepatic encephalopathy, varices on imaging/endoscopy or history of variceal bleeding, or a Model for End Stage Liver Disease (MELD) score > 10.
• Subjects who have undergone bariatric surgery within 5 years prior to the first Screening Period visit after confirming a qualifying ALT result or are planning bariatric surgery during the clinical trial.
• Subjects with a history of malignancy within 2 years prior to the first Screening Period visit. However, subjects who have completed all cancer therapies with no evidence of active malignancy within the 2 years prior to the first Screening Period visit will be allowed, except for squamous cell or basal cell carcinoma of the skin definitively treated > 12 weeks prior to the first Screening Period visit.
• Subjects who have a presence of clinically significant cardiac (including Grade III/IV heart failure as defined by the New York Heart Association Criteria [Appendix 10.2]). This includes subjects with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 90 days prior to the first Screening Period visit.
• Subjects with a history of acute cardiovascular disease (uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attack, cerebrovascular disease, etc.) within 12 weeks prior to the first Screening Period visit.
• Subjects with a history of drug abuse or alcohol addiction within 12 weeks prior to the first Screening Period visit.
• Subjects with a positive screen for drugs of abuse (ie, amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiate metabolite, and phencyclidine). Subjects who have been prescribed benzodiazepine or opiates for stable chronic medical illness may still qualify for the study at the discretion of the Investigator and review of the Medical Monitor.

Where it is running

• Southern California Research Center — Coronado, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Velocity Clinical Research, Panorama City — Panorama City, California, United States
• Inland Empire Clinical Trials, LLC — Rialto, California, United States
• Integrity Clinical Research, LLC — Doral, Florida, United States
• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Floridian Clinical Research — Miami Lakes, Florida, United States
• GI Associates & Endoscopy Center — Flowood, Mississippi, United States
• AIG Digestive Disease Research — Florham Park, New Jersey, United States
• South Texas Research Institute - A Pinnacle Entity — Edinburg, Texas, United States
• Dallas Research Institute, LLC — Farmers Branch, Texas, United States
• Pinnacle Clinical Research - Georgetown — Georgetown, Texas, United States
• Pioneer Research Solutions Inc. — Houston, Texas, United States
• American Research Corporation — San Antonio, Texas, United States
• Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States
• Apex Mobile Clinical Research, LLC — San Antonio, Texas, United States
• Liver Institute Northwest — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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