A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH

Phase 2

Active, not recruiting

• Conditions: NAFLD; NASH
• Interventions: Drug: Placebo; Drug: DD01

• Registration Number: NCT06410924
• Lead Sponsor: Neuraly, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Study First Posted: 2024-05-13
• Study Start: 2024-06-13
• Status Verified: 2025-04
• Primary Completion: 2025-04-22
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo
DD01	DD01	Study Drug

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	12 and 48 weeks
Change in glucose metabolism parameters	12 and 48 weeks	To determine the effect on glucose metabolism parameters including glucose, insulin, C-peptide and HbA1c
Change in liver steatosis as assessed by FibroScan	12 weeks and 48 weeks
Absolute change in percent liver fat content as assessed by MRI-PDFF	12 weeks and 48 weeks
Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)	12 weeks and 48 weeks
Change in liver stiffness measurements as assessed by FibroScan	12 weeks and 48 weeks
Change in liver biochemistry	12 and 48 weeks	To determine the effect in liver biochemistry parameters including ALT, AST, AST/ALT ration, Gamma-glutamyl transferase, bilirubin
Effect on pharmacokinetics as assessed by serum concentration-time profiles	Day 1 to 48 weeks

Trial Locations

Locations (1)

Summit Research Site; 🇺🇸 San Antonio, Texas, United States