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

NAFLD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410924
• Other study ID #: DD01-DN-02
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Neuraly, Inc.
• Contact: Study Director
• Phone: 240-937-5880
• Email: info[@]neuralymed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• NAFLD
• NASH
• Overweight

Intervention

Drug:
• DD01
Dual GLP-1 and glucagon receptor agonist
• Placebo
Placebo matching DD01

Locations

Country	Name	City	State
United States	Summit Research Site	Austin	Texas
United States	Summit Research Site	Bellaire	Texas
United States	Summit Research Site	Brownsville	Texas
United States	Summit Research Site	Columbus	Ohio
United States	Summit Research Site	Corpus Christi	Texas
United States	Summit Research Site	Edinburg	Texas
United States	Summit Research Site	Georgetown	Texas
United States	Summit Research Site	Kansas City	Missouri
United States	Summit Research Site	Maitland	Florida
United States	Summit Research Site	Monroe	Louisiana
United States	Summit Research Site	San Antonio	Texas
United States	Summit Research Site	San Antonio	Texas
United States	Summit Research Site	West Monroe	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Neuraly, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Histologic evidence for improvements in MASH		48 weeks
Primary	Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF		12 weeks
Secondary	Absolute change in percent liver fat content as assessed by MRI-PDFF		12 weeks and 48 weeks
Secondary	Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)		12 weeks and 48 weeks
Secondary	Change in liver stiffness measurements as assessed by FibroScan		12 weeks and 48 weeks
Secondary	Change in liver steatosis as assessed by FibroScan		12 weeks and 48 weeks
Secondary	Number of participants with Adverse Events		12 and 48 weeks
Secondary	Change in liver biochemistry	To determine the effect in liver biochemistry parameters including ALT, AST, AST/ALT ration, Gamma-glutamyl transferase, bilirubin	12 and 48 weeks
Secondary	Change in glucose metabolism parameters	To determine the effect on glucose metabolism parameters including glucose, insulin, C-peptide and HbA1c	12 and 48 weeks
Secondary	Effect on pharmacokinetics as assessed by serum concentration-time profiles		Day 1 to 48 weeks