NON-ALCOHOLIC STEATOHEPATITISPhase 2NCT06054815
Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
A Phase 2 study testing DA-1241 and Sitagliptin in people with NON-ALCOHOLIC STEATOHEPATITIS, run by NeuroBo Pharmaceuticals Inc. at 18 sites in United States.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NON-ALCOHOLIC STEATOHEPATITIS
- What is being tested?
- DA-1241 and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 18 sitesUnited States
- Study dates
- 14 Sep 2023to 30 Oct 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to understand and sign informed consent before the conduct of any protocol specific screening procedures.
- Subjects who are male or female, aged 18 to 75 years inclusive at the time of consent.
- Female subjects of childbearing potential:
- Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last dose of study drug.
- Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last dose of the study drug:
- True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable).
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- Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
- Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
- Bilateral tubal occlusion/ligation.
- Intrauterine device (IUD).
- Intrauterine hormone releasing system (IUS).
- Vasectomized partner.
- Female subjects of non-childbearing potential do not need to use birth control during or after study drug treatment if considered of non-childbearing potential due to any of the following criteria:
- Premenopausal female with permanent sterility or permanent infertility as due to one of the following:
- Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
- Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; Investigator discretion should be applied to determining study entry for these individuals.
- Postmenopausal female subjects, with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level ≥ 40 IU/L.
- Male subjects who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male subject has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last dose of the study drug.
- Subjects with a BMI > 23 kg/m2 at first Screening Period visit.
- Subjects with a qualifying ALT result (40 IU/L ≤ ALT < 200 IU/L) as determined by the laboratory assessment at the first Screening Period visit.
- Subjects with a confirmed NASH diagnosis or conditions consistent with NASH.
- Subjects with an HbA1c ≥ 5.7% and < 9.5% (5.7% ≤ HbA1c < 9.5%).
- Subjects with ≥ 8% hepatic fat on MRI after confirming a qualifying ALT result at Screening.
- Subjects with CAP score by FibroScan® of ≥ 290 dB/m at the time of the first Screening Period visit.
- Subjects with 7 kPa ≤ VCTE score by FibroScan® < 14 kPa at the time of the first Screening Period visit.
- For subjects receiving stable doses of the following medications prior to the first Screening Period visit, the following conditions applied:
- Sodium-glucose cotransporter-2 (SGLT-2): no dose changes for at least 12 weeks prior to the first Screening Period visit.
- Insulin and oral antidiabetic medications or drugs for dyslipidemia: no dose changes for at least 8 weeks prior to the first Screening Period visit; defined as a change of no more than a ± 25% in total daily dose of insulin during this period.
- Vitamin E > 400 I/U: daily dose of ≤ 800 I/U, stable for at least 12 weeks prior to the first Screening Period visit.
- HMG-CoA Reductase Inhibitor (statins): no dose changes for at least 8 weeks prior to the first Screening Period visit.
Who cannot join
- Subjects who have used an investigational agent within 30 days or 5 elimination half-lives; whichever is longer prior to the first Screening Period visit.
- Subjects diagnosed with liver disease other than NASH (eg, chronic viral hepatitis, decompensated cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, primary biliary cholangitis, drug-induced liver disease).
- Subjects who have a positive test result for hepatitis A virus immunoglobulin M, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or reactive human immunodeficiency virus (HIV) after providing a qualifying ALT result at the first Screening Period visit, or who have a known history of HIV infection. However, subjects with a positive hepatitis C virus antibody could be eligible after undergoing reflex testing (HCV-RNA negative) and evaluation by the Investigator.
- Clinically significant laboratory results as evaluated by the Investigator after providing a qualifying ALT result at the first Screening Period visit. Subjects will be excluded if:
- AST ≥ 200 U/L
- Platelets ≤ 150,000/mm3
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- Albumin < 3.8 g/dL
- Total bilirubin ≥ 1.5 mg/dl, except with clinical diagnosis of Gilbert's syndrome
- Direct bilirubin > 0.3 mg/dL
- Phosphatidylethanol > 40 ng/mL
- INR > 1.3 in the absence of anticoagulants
- Subjects with an estimated glomerular filtration rate < 60 mL/min/1.73m2 based on modification of Diet in Renal Disease (MDRD) formula.
- Subjects with a corrected QT interval by Fridericia (QTcF) of > 450 ms in males, and > 470 ms in females.
- Subjects who are taking one or more of the following medications:
- Within 12 weeks prior to the first Screening Period visit: i. Medication that is known to cause or worsen fatty liver disease (amiodarone, valproate, tamoxifen, methotrexate, etc.) for > 14 days. ii. Medication for weight loss. iii. Chronic use of systemic corticosteroids for > 14 days; however, administration of intranasal, topical, or inhaled corticosteroids is allowed. iv. DPP-4 inhibitors, thiazolidinediones (TZDs), or GLP-1 agonists.
- St. John's Wort or consuming grapefruit juice within 2 weeks prior to the first Screening Period visit.
- Digoxin, strong CYP3A4 inhibitors (a ≥ 10-fold increase in AUC of sensitive substrate), or strong CYP3A4 inducers (decreases the AUC of sensitive index substrates of a given metabolic pathway ≥ 80% increase) received within 5 half-lives or 14 days (whichever is longer) prior to the first Screening Period visit.
- Subjects who cannot get an MRI scan.
- Subjects who have a history of cirrhosis, a VCTE ≥ 14 kPa, portal hypertension as evidenced by a history of splenomegaly > 15 cm, ascites, hepatic encephalopathy, varices on imaging/endoscopy or history of variceal bleeding, or a Model for End Stage Liver Disease (MELD) score > 10.
- Subjects who have undergone bariatric surgery within 5 years prior to the first Screening Period visit after confirming a qualifying ALT result or are planning bariatric surgery during the clinical trial.
- Subjects with a history of malignancy within 2 years prior to the first Screening Period visit. However, subjects who have completed all cancer therapies with no evidence of active malignancy within the 2 years prior to the first Screening Period visit will be allowed, except for squamous cell or basal cell carcinoma of the skin definitively treated > 12 weeks prior to the first Screening Period visit.
- Subjects who have a presence of clinically significant cardiac (including Grade III/IV heart failure as defined by the New York Heart Association Criteria [Appendix 10.2]). This includes subjects with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 90 days prior to the first Screening Period visit.
- Subjects with a history of acute cardiovascular disease (uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attack, cerebrovascular disease, etc.) within 12 weeks prior to the first Screening Period visit.
- Subjects with a history of drug abuse or alcohol addiction within 12 weeks prior to the first Screening Period visit.
- Subjects with a positive screen for drugs of abuse (ie, amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiate metabolite, and phencyclidine). Subjects who have been prescribed benzodiazepine or opiates for stable chronic medical illness may still qualify for the study at the discretion of the Investigator and review of the Medical Monitor.
- Subjects who have physical (severe disorders in liver, heart, kidney, lung, blood, endocrine system, musculoskeletal system, gastrointestinal system, etc.) or mental (cognitive impairment, mental illness) conditions that may affect the subject's ability to participate in the clinical trial.
- If female, subjects who are pregnant or lactating or intend to become pregnant during the clinical trial.
- If male, subjects who intend to impregnate a partner.
- Subjects who intend to donate ova or sperm during the clinical trial.
- Subjects with known or suspected intolerance or hypersensitivity to IPs, closely-related compounds, or any of the stated ingredients.
- Subjects with a weight change of > 10% measured at the first Screening Period and TP1 visits.
- Subjects who cannot communicate reliably with the Investigator or are unlikely to cooperate with the requirements of the clinical trial.
- Subjects with any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in, or completion of, the clinical trial.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Southern California Research Center
Coronado, California, 92118
Integrity Clinical Research, LLC
Doral, Florida, 33122
South Texas Research Institute - A Pinnacle Entity
Edinburg, Texas, 78539
Dallas Research Institute, LLC
Farmers Branch, Texas, 75234
AIG Digestive Disease Research
Florham Park, New Jersey, 07932
GI Associates & Endoscopy Center
Flowood, Mississippi, 39232
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
Pioneer Research Solutions Inc.
Houston, Texas, 77099
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Suncoast Research Group, LLC
Miami, Florida, 33135
Floridian Clinical Research
Miami Lakes, Florida, 33016
Catalina Research Institute, LLC
Montclair, California, 91763
Velocity Clinical Research, Panorama City
Panorama City, California, 91402
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
American Research Corporation
San Antonio, Texas, 78215
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
Apex Mobile Clinical Research, LLC
San Antonio, Texas, 78258
Liver Institute Northwest
Seattle, Washington, 98105
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
Read the detailed description
Clinical trial DA1241_NASH_IIa is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with presumed NAFLD.
Part 1 of this clinical trial intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 at varying doses or identical placebo in 3 treatment groups for 16 weeks/112 days.
Part 2 intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 in combination with sitagliptin versus an identical placebo for 16 weeks/112 days.
- Conditions
- NON-ALCOHOLIC STEATOHEPATITIS
- Being tested
- DA-1241, Sitagliptin, DA-1241 Placebo, Sitagliptin Placebo
- Keywords
- NASH, NON-ALCOHOLIC STEATOHEPATITIS
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1241Drug
Route of Administration: Oral, with subjects in a fasting state
SitagliptinDrug
Route of Administration: Oral, with subjects in a fasting state
DA-1241 PlaceboDrug
Route of Administration: Oral, with subjects in a fasting state
Sitagliptin PlaceboDrug
Route of Administration: Oral, with subjects in a fasting state
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Group 1 | Experimental | DA-1241 Dose 1
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. Receives: Drug: DA-1241; Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo |
| Part 1 Group 2 | Experimental | DA-1241 Dose 2
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. Receives: Drug: DA-1241; Drug: Sitagliptin Placebo |
| Part 1 Group 3.1 | Placebo comparator | DA-1241 Placebo and Sitagliptin Placebo
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. Receives: Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo |
| Part 2 Group 3.2 | Placebo comparator | DA-1241 Placebo and Sitagliptin Placebo
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. Receives: Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo |
| Part 2 Group 4 | Experimental | DA-1241 and Sitagliptin
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. Receives: Drug: DA-1241; Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change alanine transaminase (ALT) levels
To explore the efficacy (change from baseline in alanine transaminase [ALT]) of DA-1241 in subjects at risk of NASH or subjects with non-alcoholic fatty liver disease (NAFLD) after administration of oral DA-1241 at varying doses of placebo and in combination with sitagliptin.
Measured: Baseline to Day 112
Secondary outcomes (12)
ALT Normalization
Proportion of subjects with normalization of ALT: < 30 IU/L
Measured: Baseline to Day 112
AST, GGT, ALP
Absolute change in aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT), and alkaline phosphatase (ALP).
Measured: Baseline to Day 112
Total cholesterol, LDL, HDL, triglyceride, and free fatty acids
Absolute change in total cholesterol, low and high-density lipoprotein cholesterol, triglyceride, and free fatty acids from baseline.
Measured: Baseline to Day 112
A1c
Absolute change in hemoglobin A1c (HbA1c) (%).
Measured: Baseline to Day 112
Glucose
Absolute change in fasting plasma glucose (mg/dL).
Measured: Baseline to Day 112
Fasting insulin
Absolute change in fasting insulin.
Measured: Baseline to Day 112
HOMA-IR
Absolute change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Measured: Baseline to Day 112
Adipo-IR
Absolute change in adipose tissue insulin resistance index (adipo-IR).
Measured: Baseline to Day 112
CAP
Absolute change in controlled attenuation parameter (CAP) score assessed by FibroScan®.
Measured: Baseline to Day 112
VCTE
Absolute change in vibration-controlled transient elastography (VCTE) score assessed by FibroScan®.
Measured: Baseline to Day 112
FAST
Absolute change in FibroScan®- AST (FAST) score.
Measured: Baseline to Day 112
Body weight
Absolute change in body weight.
Measured: Baseline to Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start14 Sep 2023
- Primary completion24 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NON-ALCOHOLIC STEATOHEPATITISStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054815
- Sponsor's protocol ID
- DA1241_NASH_IIa
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT06054815
- Acronym / sponsor ID
- DA1241_NASH_IIa
- Conditions
- NON-ALCOHOLIC STEATOHEPATITIS
- Keywords
- NASH, NON-ALCOHOLIC STEATOHEPATITIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 26 Sep 2023 (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.
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
Detailed description
Clinical trial DA1241_NASH_IIa is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with presumed NAFLD.
Part 1 of this clinical trial intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 at varying doses or identical placebo in 3 treatment groups for 16 weeks/112 days.
Part 2 intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 in combination with sitagliptin versus an identical placebo for 16 weeks/112 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Group 1 | Experimental | Drug: DA-1241, Drug: DA-1241 Placebo, Drug: Sitagliptin PlaceboDA-1241 Dose 1 In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 1 Group 2 | Experimental | Drug: DA-1241, Drug: Sitagliptin PlaceboDA-1241 Dose 2 In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 1 Group 3.1 | Placebo comparator | Drug: DA-1241 Placebo, Drug: Sitagliptin PlaceboDA-1241 Placebo and Sitagliptin Placebo In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 2 Group 3.2 | Placebo comparator | Drug: DA-1241 Placebo, Drug: Sitagliptin PlaceboDA-1241 Placebo and Sitagliptin Placebo In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. |
| Part 2 Group 4 | Experimental | Drug: DA-1241, Drug: SitagliptinDA-1241 and Sitagliptin In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Subjects who are able to understand and sign informed consent before the conduct of any protocol specific screening procedures.
- Subjects who are male or female, aged 18 to 75 years inclusive at the time of consent.
- Female subjects of childbearing potential:
- Female subjects of non-childbearing potential do not need to use birth control during or after study drug treatment if considered of non-childbearing potential due to any of the following criteria:
- Male subjects who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male subject has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last dose of the study drug.
Key exclusion criteria (33 listed)
- Subjects who have used an investigational agent within 30 days or 5 elimination half-lives; whichever is longer prior to the first Screening Period visit.
- Subjects diagnosed with liver disease other than NASH (eg, chronic viral hepatitis, decompensated cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, primary biliary cholangitis, drug-induced liver disease).
- Subjects who have a positive test result for hepatitis A virus immunoglobulin M, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or reactive human immunodeficiency virus (HIV) after providing a qualifying ALT result at the first Screening Period visit, or who have a known history of HIV infection. However, subjects with a positive hepatitis C virus antibody could be eligible after undergoing reflex testing (HCV-RNA negative) and evaluation by the Investigator.
- Clinically significant laboratory results as evaluated by the Investigator after providing a qualifying ALT result at the first Screening Period visit. Subjects will be excluded if:
- Subjects with an estimated glomerular filtration rate < 60 mL/min/1.73m2 based on modification of Diet in Renal Disease (MDRD) formula.
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 |
|---|---|---|
| DA-1241Route of Administration: Oral, with subjects in a fasting state | Drug | Part 1 Group 1, Part 1 Group 2, Part 2 Group 4 |
| SitagliptinRoute of Administration: Oral, with subjects in a fasting state | Drug | Part 2 Group 4 |
| DA-1241 PlaceboRoute of Administration: Oral, with subjects in a fasting state | Drug | Part 1 Group 1, Part 1 Group 3.1, Part 2 Group 3.2 |
| Sitagliptin PlaceboRoute of Administration: Oral, with subjects in a fasting state | Drug | Part 1 Group 1, Part 1 Group 2, Part 1 Group 3.1, Part 2 Group 3.2 |
Primary outcome
Change alanine transaminase (ALT) levels
Time frame: Baseline to Day 112
To explore the efficacy (change from baseline in alanine transaminase [ALT]) of DA-1241 in subjects at risk of NASH or subjects with non-alcoholic fatty liver disease (NAFLD) after administration of oral DA-1241 at varying doses of placebo and in combination with sitagliptin.
12 secondary outcomes
ALT Normalization
Time frame: Baseline to Day 112
AST, GGT, ALP
Time frame: Baseline to Day 112
Total cholesterol, LDL, HDL, triglyceride, and free fatty acids
Time frame: Baseline to Day 112
A1c
Time frame: Baseline to Day 112
Glucose
Time frame: Baseline to Day 112
Fasting insulin
Time frame: Baseline to Day 112
HOMA-IR
Time frame: Baseline to Day 112
Adipo-IR
Time frame: Baseline to Day 112
CAP
Time frame: Baseline to Day 112
VCTE
Time frame: Baseline to Day 112
FAST
Time frame: Baseline to Day 112
Body weight
Time frame: Baseline to Day 112
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 14 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 DA-1241 and Sitagliptin in people with NON-ALCOHOLIC STEATOHEPATITIS, run by NeuroBo Pharmaceuticals Inc. at 18 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 30 inclusion and 33 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Change alanine transaminase (ALT) levels (time frame: Baseline to Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2024.