NAFLDPhase 2NCT06410924
A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH
A Phase 2 study testing DD01 in people with NAFLD and NASH, run by Neuraly, Inc. at 12 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- DD01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 12 sitesUnited States
- Study dates
- 13 Jun 2024to 21 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Summit Research Site
Austin, Texas, 78757
Summit Research Site
Bellaire, Texas, 77401
Summit Research Site
Brownsville, Texas, 78520
Summit Research Site
Corpus Christi, Texas, 78404
Summit Research Site
Edinburg, Texas, 78539
Summit Research Site
Georgetown, Texas, 78626
Summit Research Site
Kansas City, Missouri, 64131
Summit Research Site
Maitland, Florida, 92751
Summit Research Site
Monroe, Louisiana, 71201
Summit Research Site
San Antonio, Texas, 78222
Summit Research Site
San Antonio, Texas, 78229
Summit Research Site
West Monroe, Louisiana, 71291
About this study
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
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).
- Being tested
- DD01, Placebo
- Keywords
- Liver Disease, Fatty Liver, Non-alcoholic fatty liver disease, Non-alcoholic steatohepatitis, MASH, MASLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DD01Drug
Dual GLP-1 and glucagon receptor agonist
PlaceboDrug
Placebo matching DD01
| Study group | Role | What they receive |
|---|---|---|
| DD01 | Experimental | Study Drug Receives: Drug: DD01 |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
Measured: 12 weeks
Secondary outcomes (8)
Absolute change in percent liver fat content as assessed by MRI-PDFF
Measured: 12 weeks and 48 weeks
Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)
Measured: 12 weeks and 48 weeks
Change in liver stiffness measurements as assessed by FibroScan
Measured: 12 weeks and 48 weeks
Change in liver steatosis as assessed by FibroScan
Measured: 12 weeks and 48 weeks
Number of participants with Adverse Events
Measured: 12 and 48 weeks
Change in liver biochemistry
To determine the effect in liver biochemistry parameters including ALT, AST, AST/ALT ration, Gamma-glutamyl transferase, bilirubin
Measured: 12 and 48 weeks
Change in glucose metabolism parameters
To determine the effect on glucose metabolism parameters including glucose, insulin, C-peptide and HbA1c
Measured: 12 and 48 weeks
Effect on pharmacokinetics as assessed by serum concentration-time profiles
Measured: Day 1 to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start13 Jun 2024
- Primary completion20 May 2025
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuraly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis To, Study director, Neuraly, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410924
- Sponsor's protocol ID
- DD01-DN-02
- Status last verified
- Apr 2026
- First submitted
- 8 May 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Noureddin M, Dunn W, Patil R, Desai D, Puskoor R, Shin J, To D, Bell AC, Lee DR, Lin YH, Lee S. The glucagon and GLP-1 receptor dual agonist DD01 for metabolic dysfunction-associated steatotic liver disease and steatohepatitis (DD01-DN-02): 12-week results from a randomised, double-blind, multicentre, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Jul 21:S2468-1253(26)00130-5. doi: 10.1016/S2468-1253(26)00130-5. Online ahead of print.
PubMed 42480572
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06410924
- Acronym / sponsor ID
- DD01-DN-02
- Keywords
- Liver Disease, Fatty Liver, Non-alcoholic fatty liver disease, Non-alcoholic steatohepatitis, MASH, MASLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Neuraly, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD01 | Experimental | Drug: DD01Study Drug |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DD01Dual GLP-1 and glucagon receptor agonist | Drug | DD01 |
| PlaceboPlacebo matching DD01 | Drug | Placebo |
Primary outcome
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
Time frame: 12 weeks
8 secondary outcomes
Absolute change in percent liver fat content as assessed by MRI-PDFF
Time frame: 12 weeks and 48 weeks
Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)
Time frame: 12 weeks and 48 weeks
Change in liver stiffness measurements as assessed by FibroScan
Time frame: 12 weeks and 48 weeks
Change in liver steatosis as assessed by FibroScan
Time frame: 12 weeks and 48 weeks
Number of participants with Adverse Events
Time frame: 12 and 48 weeks
Change in liver biochemistry
Time frame: 12 and 48 weeks
Change in glucose metabolism parameters
Time frame: 12 and 48 weeks
Effect on pharmacokinetics as assessed by serum concentration-time profiles
Time frame: Day 1 to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42480572Noureddin M, Dunn W, Patil R, Desai D, Puskoor R, Shin J, To D, Bell AC, Lee DR, Lin YH, Lee S. The glucagon and GLP-1 receptor dual agonist DD01 for metabolic dysfunction-associated steatotic liver disease and steatohepatitis (DD01-DN-02): 12-week results from a randomised, double-blind, multicentre, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Jul 21:S2468-1253(26)00130-5. doi: 10.1016/S2468-1253(26)00130-5. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis To study director
Neuraly, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DD01 in people with NAFLD and NASH, run by Neuraly, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.