A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

ClinicalTrials.gov ID

NCT02815891

Acronym / sponsor ID

TARGET-NASH

Conditions

Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis

Study type

Observational

Recruitment status

Completed

Enrolment

7,330 participants (actual)

Lead sponsor

Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)

Study start

Jul 2016

Primary completion

May 2026 (actual)

Study completion

May 2026 (actual)

First posted

28 Jun 2016 (estimated)

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.

Study design

Observational model

Cohort

Time perspective

Other

Target follow-up

5 Years

Who may qualify

Ages

2 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Adults and children with NAFL or NASH who are being seen specifically to address this disease process

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Establish an understanding of the current natural history of NASH at academic and community medical centers

   Time frame: 10 years

   A detailed analysis of demographics, concurrent medications, metabolic and cardiovascular co-morbidities, staging of liver disease, and outcomes for patients with NASH managed in diverse clinical settings will serve as an important comparator for subsequent interventions that alter the treatment paradigm for this disease.

2. Evaluate NASH treatment regimens being used in clinical practice

   Time frame: 10 years

   Currently, there are no FDA approved therapies for NASH, however clinicians may use a variety of interventions including diet and exercise programs, vitamin E, bariatric surgery or other unapproved uses of some cholesterol, lipid lowering, anti-diabetic and anti-inflammatory medications as well as alternative medications. TARGET-NASH will monitor the safety and effectiveness of the various treatment choices in enrolled patients.

3. Examine populations underrepresented in phase II-III clinical trials

   Time frame: 10 years

   Patients with cirrhosis, age > 70, patients who consume moderate amounts of alcohol and patients with multiple comorbidities such as severe depression, chronic fatigue, fibromyalgia, type 2 diabetes, inflammatory bowel disease, or cardiovascular disease.

4. Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission

   Time frame: 10 years

   In addition to diet and exercise, type, dose and duration of therapy of each NASH treatment (both current unapproved therapies and future FDA approved drugs) will be closely followed, with a goal to monitor treatment paradigms and various combination regimens for clinical response and clinical remission.

5. Examine liver histology

   Time frame: 10 years

6. Estimate adverse event frequency and severity and describe management practices

   Time frame: 10 years

   NASH can often be an asymptomatic disease in the setting of other disease-related comorbidities such as diabetes and cardiovascular disease. Once NASH progresses to cirrhosis, these patients can suffer the attendant complications of decompensated liver disease including debilitating fatigue, muscle wasting, ascites, bleeding, encephalopathy, hepatocellular carcinoma, and death. NASH therapies may increase the frequency and severity of certain adverse events, such as edema (pioglitazone), some cancers (vitamin E), and new agents or combinations of agents may have their own unique adverse event profiles and varying needs for management plans (e.g., pruritus and dyslipidemia).

7. Evaluate the impact of NASH therapies on medical co-morbidities

   Time frame: 10 years

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 13 May 2026.
• Derived from this study: PubMed 39739194Luthra R, Sheth A. Understanding MASH: An Examination of Progression and Clinical Outcomes by Disease Severity in the TARGET-NASH Database. Adv Ther. 2025 Feb;42(2):1165-1195. doi: 10.1007/s12325-024-03085-4. Epub 2024 Dec 30.
• Derived from this study: PubMed 39401124Sanchez-Torres C, Ramirez Tovar A, Chatman K, Morris HL, Yu F, Mospan AR, Diehl AM, Leung DH, Viswanathan P, Squires JE, Palle S, Vos MB. Concordance of MASLD and NAFLD nomenclature in youth participating in the TARGET-NASH real-world cohort. Hepatol Commun. 2024 Oct 10;8(11):e0546. doi: 10.1097/HC9.0000000000000546. eCollection 2024 Nov 1. No abstract available.
• Derived from this study: PubMed 36871772Sanyal AJ, Munoz B, Cusi K, Barritt AS 4th, Muthiah M, Mospan AR, Reddy KR, Firpi-Morell R, Thuluvath PJ, Bhamidimarri KR, Fried MW; TARGET-NASH Investigators. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2889-2900.e10. doi: 10.1016/j.cgh.2023.02.024. Epub 2023 Mar 5.
• Derived from this study: PubMed 33486083Malespin MH, Barritt AS 4th, Watkins SE, Schoen C, Tincopa MA, Corbin KD, Mospan AR, Munoz B, Trinh HN, Weiss LM, Reddy KR, Loomba R, Kemmer N, Lok AS. Weight Loss and Weight Regain in Usual Clinical Practice: Results From the TARGET-NASH Observational Cohort. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2393-2395.e4. doi: 10.1016/j.cgh.2021.01.023. Epub 2021 Jan 21.
• Derived from this study: PubMed 32629123Weinberg EM, Trinh HN, Firpi RJ, Bhamidimarri KR, Klein S, Durlam J, Watkins S, Reddy KR, Weiss M, Zink RC, Lok AS. Lean Americans With Nonalcoholic Fatty Liver Disease Have Lower Rates of Cirrhosis and Comorbid Diseases. Clin Gastroenterol Hepatol. 2021 May;19(5):996-1008.e6. doi: 10.1016/j.cgh.2020.06.066. Epub 2020 Jul 3.
• Individual participant dataSharing planned: No

Related trials for Nonalcoholic Fatty Liver

• Not yet recruiting

  Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors

  Hepatic Steatosis, Fatty Liver

• RecruitingPhase 3

  A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

  NASH With Fibrosis, MASH With Fibrosis

• Recruiting

  NAFLD Clinical Care Pathway

  NAFLD, MASLD

• RecruitingPhase 3

  Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

  Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

• RecruitingPhase 1

  A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

  Non-alcoholic Fatty Liver Disease

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.

72 sites in 3 countries: see every site and its status.