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DA-1241 + Sitagliptin for Non-alcoholic Fatty Liver Disease

Verified Trial
Phase 2
Recruiting
Research Sponsored by NeuroBo Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- 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).
- Bilateral tubal occlusion/ligation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 112
Awards & highlights

Study Summary

This trial tests if a new drug is safe and effective for people with NASH, a liver disease.

Who is the study for?
Adults aged 18-75 with presumed non-alcoholic steatohepatitis (NASH), a BMI over 23, and specific liver fat content on MRI. They must have stable medication doses if taking certain drugs and agree to contraception requirements. Excluded are those with other liver diseases, recent investigational drug use, or significant lab abnormalities.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of DA-1241 compared to placebo in treating NASH. It's a Phase 2a study where participants are randomly assigned to receive either DA-1241 or placebo in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.See study design
What are the potential side effects?
Potential side effects for DA-1241 aren't specified but may include typical drug reactions such as gastrointestinal discomfort, headaches, fatigue, allergic reactions or skin issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I practice true abstinence as part of my lifestyle.
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I have had both of my fallopian tubes surgically blocked.
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I am permanently sterile due to surgery.
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I am a postmenopausal woman with no periods for 12+ months and high FSH levels.
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I have been diagnosed with NASH or have conditions similar to NASH.
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My liver has at least 8% fat, confirmed by MRI and ALT tests.
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My statin dose has been stable for at least 8 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 112 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change alanine transaminase (ALT) levels
Secondary outcome measures
A1c
ALT Normalization
AST, GGT, ALP
+9 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Group 4Experimental Treatment2 Interventions
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.
Group II: Part 1 Group 2Experimental Treatment2 Interventions
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.
Group III: Part 1 Group 1Experimental Treatment3 Interventions
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.
Group IV: Part 2 Group 3.2Placebo Group2 Interventions
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.
Group V: Part 1 Group 3.1Placebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitagliptin Placebo
2009
Completed Phase 3
~320
Sitagliptin
2011
Completed Phase 4
~10170
DA-1241
2018
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

NeuroBo Pharmaceuticals Inc.Lead Sponsor
14 Previous Clinical Trials
1,246 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor involve individuals aged 45 or over?

"In accordance with the entry qualifications, the minimum eligible age for this trial is 18 and participants must not exceed 75 years old."

Answered by AI

What are the geographical loci of this clinical trial?

"The 6 clinical trial sites participating in this research are: South Texas Research Institute - A Pinnacle Entity in Edinburg, Pinnacle Clinical Research - Georgetown in Georgetown, American Research Corporation in San Antonio and 3 additional locations."

Answered by AI

What are the prerequisites to be eligible for enrollment in this clinical trial?

"Aspiring participants must have a diagnosis of non-alcoholic fatty liver disease and fall within the specified age range (18 - 75) to be considered for this experiment. Approximately 87 individuals will be recruited in total."

Answered by AI

How many individuals are actively engaged in this clinical experiment?

"Yes, as evidenced by the clinicaltrials.gov database, this research effort is currently recruiting. The trial was initially advertised on September 14th 2023 and updated lastly on September 19th of the same year with a goal to recruit 87 individuals from 6 distinct sites."

Answered by AI

What risks are posed by Part 1 Group 1 to individuals taking part in the trial?

"Our team at Power gauged the safety of Part 1 Group 1 to be a 2 on an established scale. This is due to this being a Phase 2 trial, which suggests that while there is evidence supporting its security, none exists for it's effectiveness yet."

Answered by AI

Are there vacancies currently available for this research trial?

"Affirmative. Per clinicaltrials.gov, this medical trial is presently accepting patients as of its last edit on September 19th 2023; the study was first posted to the website on September 14th 2023 and requires 87 individuals from 6 different sites for participation."

Answered by AI

Who else is applying?

What site did they apply to?
Pinnacle Clinical Research - Georgetown
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
2023. "Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054815.
All > Fatty Liver > Januvia
~26 spots leftby Aug 2024
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