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Clinical Trials List

Protocol NumberN1T-MC-MALO

NCT Number(ClinicalTrials.gov Identfier)NCT07165028

Active

2026-01-01 - 2032-03-10

Phase III

Not yet recruiting8

Recruiting7

ICD-10E75.21

Fabry (-Anderson) disease

ICD-10E75.22

Gaucher disease

ICD-10E75.240

Niemann-Pick disease type A

ICD-10E75.241

Niemann-Pick disease type B

ICD-10E75.242

Niemann-Pick disease type C

ICD-10E75.243

Niemann-Pick disease type D

ICD-10E75.248

Other Niemann-Pick disease

ICD-10E75.249

Niemann-Pick disease, unspecified

ICD-10E75.3

Sphingolipidosis, unspecified

ICD-10E77.0

Defects in post-translational modification of lysosomal enzymes

ICD-10E77.1

Defects in glycoprotein degradation

ICD-10E77.8

Other disorders of glycoprotein metabolism

ICD-10E77.9

Disorder of glycoprotein metabolism, unspecified

ICD-9272.7

Lipidoses

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants with Metabolic Dysfunction-Associated Steatotic Liver Disease who are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes)

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor

ELI LILLY AND COMPANY(TAIWAN), INC.
Trial scale

Multi-Regional Multi-Center
Update

2026/09/11

Investigators and Locations

Principal Investigator Jing-Houng Wang Digestive System Department

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

郭垣宏 Digestive System Department
紀廣明 Digestive System Department
顏毅豪 Digestive System Department
盧勝男 Digestive System Department
郭芳穎 Division of Others
張國欽 Digestive System Department
陳建宏 Digestive System Department
洪肇宏 Digestive System Department
沈峰志 Division of Endocrinology
蔡明釗 Digestive System Department
歐信佑 Division of Radiology

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TENG-YU LEE

Taichung Veterans General Hospital

Co-Principal Investigator

林穎正 Digestive System Department
蔡炘儒 Digestive System Department
廖苡君 Digestive System Department
李少武 Digestive System Department
林宛姿 Digestive System Department
蘇德晟 Division of Radiology
呂宜達
陳家昌 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jia-Horng Kao Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

Chun-Jen Liu Division of General Internal Medicine
楊宏志 Division of General Internal Medicine
Shih-Jer Hsu Division of General Internal Medicine
洪俊銘 Division of General Internal Medicine
蘇東弘 Division of General Internal Medicine
曾岱宗 Division of General Internal Medicine
Chen-Hua Liu Division of General Internal Medicine
吳志宏 Division of Radiology
陳欣妤 Division of Radiology

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Yu Kao Digestive System Department

Taipei Medical University Hospital

Co-Principal Investigator

葉欣榮 Digestive System Department
Tiong Cheng Digestive System Department
Chien-Yi Hsu Division of Cardiovascular Diseases
Chun-Chao Chang Digestive System Department
陳文昭 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

吳啟榮 Digestive System Department
李癸汌 Digestive System Department
齊振達 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Lung Yu Digestive System Department

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

王志文 Digestive System Department
Chia-Yen Dai Digestive System Department
Wan-Long Chuang Digestive System Department
Chung-Feng Huang Digestive System Department
Jee-Fu Huang Digestive System Department
Ming-Lun Yeh Digestive System Department
梁博程 Digestive System Department
魏鈺儒 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Cheng-Yuan Peng Digestive System Department

China Medical University Hospital

Co-Principal Investigator

Hung-Wei Wang Digestive System Department
Wei-Fan Hsu Digestive System Department
Hsueh-Chou Lai Digestive System Department

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pin-Nan Cheng Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

Chiu Hung Chiu Digestive System Department
邱彥程 Digestive System Department
簡世杰 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hai-Hua Chuang Division of Family Medicine

Cathay General Hospital

Co-Principal Investigator

胡瑞庭 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 周莒光 Digestive System Department

Chia-Yi Christian Hosptal

Co-Principal Investigator

張力仁 Digestive System Department
鄭雅綺 Division of Family Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王嘉齊 Digestive System Department

Taipei Tzu Chi Hospital

Co-Principal Investigator

李忠憲 Digestive System Department
羅培瑞 Division of Radiology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭行道 Digestive System Department

Chi Mei Medical Center

Co-Principal Investigator

王品貽 Digestive System Department
Hao-Chang Hung Digestive System Department
馮意哲 Digestive System Department
楊畯棋 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許耀峻 Digestive System Department

E-DA Hospital

Co-Principal Investigator

王文𤦎 Digestive System Department
王朝平 Division of Cardiovascular Diseases
宣錦峰 Division of Cardiovascular Diseases
陳子皓 Digestive System Department
陳志城 Digestive System Department
曾上宸 Digestive System Department
曾政豪 Digestive System Department
蔡英楠 Digestive System Department
盧永川 Division of Endocrinology
戴啓明 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張吉仰 Digestive System Department

Fu Jen Catholic University Hospital

Co-Principal Investigator

吳冠緯 Digestive System Department
宋寬益 Digestive System Department
李輔仁 Digestive System Department
邱毓澤 Digestive System Department
施玲娜 Digestive System Department
范之仲 Digestive System Department
梁凱舜 Digestive System Department
郭震亞 Digestive System Department
陳昱宗 Digestive System Department
黃俊穎 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Wei Hsu

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Yi-Cheng Chen Digestive System Department
Yi-Chung Hsieh Digestive System Department
鄭雅婷 Digestive System Department
賴盈傑 Division of Radiology
譚欣媛 Division of Ophthalmology

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Metabolic Dysfunction-Associated Steatotic Liver Disease

Objectives

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.

Test Drug

Retatrutide (LY3437943)
Tirzepatide (LY3298176)

Active Ingredient

LY3437943
LY3298176

Dosage Form

Injection
Injection

Dosage

MG/ML
MG/ML

Endpoints

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality Baseline up to Study Completion (about 224 weeks)

Inclution Criteria

Have liver fat content ≥8%
Have ELF score of ≥9 and ≤10.8 at screening
Have VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening

Exclusion Criteria

Have any other type of liver disease other than MASLD
Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)
Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
Have lost more than 11 pounds within the 3 months prior to screening
Have a hemoglobin A1c (HbA1c) greater than 10%
Have type 1 diabetes

The Estimated Number of Participants

Taiwan

120 participants
Global

4500 participants