Clinical trial NCT06410924: A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Treatment With DD01 for 48 Weeks in Overweight/Obese Subjects With MASLD/MASH
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: NAFLD
NASH
Keywords: Liver Disease
Fatty Liver
Non-alcoholic fatty liver disease
Non-alcoholic steatohepatitis
MASH
MASLD
Lead sponsor: Neuraly, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).


Eligibility criteria: Inclusion Criteria:

* Male or Female, 18 to 70 years of age
* With MASLD or confirmed diagnosis of MASH based on MRI PDFF ≥10% AND 1 of the following:

  1. Biopsy proven MASH obtained during Screening which confirms the presence of MASH characterized by a NAS ≥4 with at least 1 in each component (steatosis, ballooning, and lobular inflammation) and fibrosis stage F1 to F3. A historical biopsy obtained within 6 months may be acceptable OR
  2. Meets at least 2 additional metabolic syndrome factors
* Participants with a BMI ≥25 kg/m2, with stable body weight by history for 3 months
* Participants must have a waist circumference ≥35 inches (females), or ≥40 inches (males), and must have a waist circumference ≤57 inches (both males and females)
* Female participants must be non-pregnant, non-lactating or post-menopausal
* Participants must have the ability and willingness to comply with all Protocol procedures, provide written informed consent and meet all inclusion criteria as outlined in the study protocol

Exclusion Criteria: Participants who have:

* A history of active or chronic liver disease
* Liver cirrhosis (fibrosis stage F4), any prior history of hepatic decompensation, including low platelet counts, esophageal varices, ascites, hepatic encephalopathy, splenomegaly, any hospitalization for treatment of chronic liver disease, or a Model for End Stage Liver Disease score of ≥12
* Recent (within 3 months of Screening) use of therapies associated with development of MASLD/MASH (eg, systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines)
* Previous surgical treatment for obesity as well as clinically significant GI disorders
* Type 1 diabetes mellitus, or T2DM on insulin and/or GLP-1 receptor agonist therapy, dipeptidyl peptidase-4 inhibitors, or other therapies
* Uncontrolled hypertension or uncontrolled dyslipidemia
* Participated in an investigational study within 30 days prior to dosing or who have participated in another MASLD/MASH interventional study within 60 days prior to Screening
* With a history or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, symptomatic cholelithiasis and/or choledocholithiasis, or alcohol abuse
* With a history of any major surgery within 3 months prior to Screening
* With heart failure (New York Heart Association Class III or IV) or any cardiovascular event or evidence of active cardiovascular disease
* With a presence of clinically significant 12-lead ECG findings at Screening, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Screening
* With personal or family history of medullary thyroid carcinoma (MTC)
* With a history of renal disease
* With a history of alcohol or illicit drug abuse
* A positive test for hepatitis B surface antigen, hepatitis C RNA, or HIV type 1 or type 2 antibody
* A clinically significant physical examination, ECG, or laboratory finding, as judged by the Investigator, may interfere with any aspect of study conduct or interpretation of results
* Not met any other exclusion criteria as outlined in the study protocol

Primary outcomes:
measure: Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
timeFrame: 12 weeks
Secondary outcomes:
measure: Absolute change in percent liver fat content as assessed by MRI-PDFF
timeFrame: 12 weeks and 48 weeks
measure: Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)
timeFrame: 12 weeks and 48 weeks
measure: Change in liver stiffness measurements as assessed by FibroScan
timeFrame: 12 weeks and 48 weeks
measure: Change in liver steatosis as assessed by FibroScan
timeFrame: 12 weeks and 48 weeks
measure: Number of participants with Adverse Events
timeFrame: 12 and 48 weeks
measure: Change in liver biochemistry
timeFrame: 12 and 48 weeks
measure: Change in glucose metabolism parameters
timeFrame: 12 and 48 weeks
measure: Effect on pharmacokinetics as assessed by serum concentration-time profiles
timeFrame: Day 1 to 48 weeks
Other outcomes:
measure: Histologic evidence for improvements in MASH
timeFrame: 48 weeks
Locations:
city: Maitland
country: United States
facility: Summit Research Site
state: Florida
city: Monroe
country: United States
facility: Summit Research Site
state: Louisiana
city: West Monroe
country: United States
facility: Summit Research Site
state: Louisiana
city: Kansas City
country: United States
facility: Summit Research Site
state: Missouri
city: Austin
country: United States
facility: Summit Research Site
state: Texas
city: Bellaire
country: United States
facility: Summit Research Site
state: Texas
city: Brownsville
country: United States
facility: Summit Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Summit Research Site
state: Texas
city: Edinburg
country: United States
facility: Summit Research Site
state: Texas
city: Georgetown
country: United States
facility: Summit Research Site
state: Texas
city: San Antonio
country: United States
facility: Summit Research Site
state: Texas
city: San Antonio
country: United States
facility: Summit Research Site
state: Texas
Study officials:
affiliation: Neuraly, Inc.
name: Dennis To
role: STUDY_DIRECTOR
References: