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

NCT06410924 | Completed Phase 2 FDA Drug

• 1 other identifier: DD01-DN-02
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 12

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).

Conditions

NAFLD; NASH

Keywords

Liver Disease; Fatty Liver; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; MASH; MASLD

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF

  12 weeks

Secondary Outcomes (8)

• 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 steatosis as assessed by FibroScan

  12 weeks and 48 weeks

• Number of participants with Adverse Events

  12 and 48 weeks

Other Outcomes (1)

• Histologic evidence for improvements in MASH

  48 weeks

Study Arms (2)

DD01

EXPERIMENTAL

Study Drug

Drug: DD01

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

DD01 DRUG

Dual GLP-1 and glucagon receptor agonist

DD01

Placebo DRUG

Placebo matching DD01

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuraly, Inc.: lead

Study Sites (12)

Summit Research Site

Maitland, Florida, 92751, United States

Location

Summit Research Site

Monroe, Louisiana, 71201, United States

Location

Summit Research Site

West Monroe, Louisiana, 71291, United States

Location

Summit Research Site

Kansas City, Missouri, 64131, United States

Location

Summit Research Site

Austin, Texas, 78757, United States

Location

Summit Research Site

Bellaire, Texas, 77401, United States

Location

Summit Research Site

Brownsville, Texas, 78520, United States

Location

Summit Research Site

Corpus Christi, Texas, 78404, United States

Location

Summit Research Site

Edinburg, Texas, 78539, United States

Location

Summit Research Site

Georgetown, Texas, 78626, United States

Location

Summit Research Site

San Antonio, Texas, 78222, United States

Location

Summit Research Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Fatty Liver

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Dennis To

  Neuraly, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: June 13, 2024
• Primary Completion: May 20, 2025
• Study Completion: April 21, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (12)