GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

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

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

Lead sponsor

Neuraly, Inc.

Asset

DD01

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥25

Primary endpoint

•MRI-PDFF ≥30% responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06410924

Org study IDDD01-DN-02

Timeline

Milestones

Study first posted2024-05-13actual

Study start2024-06-13actual

Primary completion2025-05-20actual

Study completion2026-04-21actual

Last update posted2026-05-01actual

Assets

Investigational agents

DD01

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

Change in glucose metabolism parameters

Time frame:12 and 48 weeks

change from baseline, improvement

MASH / liver

7 endpoints

Primary/protocol endpoint

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

Time frame:12 weeks

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change in percent liver fat content as assessed by MRI-PDFF

Time frame:12 weeks and 48 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)

Time frame:12 weeks and 48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness measurements as assessed by FibroScan

Time frame:12 weeks and 48 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Change in liver steatosis as assessed by FibroScan

Time frame:12 weeks and 48 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Change in liver biochemistry

Time frame:12 and 48 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Histologic evidence for improvements in MASH

Time frame:48 weeks

categorical status, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of participants with Adverse Events

Time frame:12 and 48 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Effect on pharmacokinetics as assessed by serum concentration-time profiles

Time frame:Day 1 to 48 weeks

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.