Actively Recruiting
A Study of CS060380 Tablets in Patients With MASH and Obesity
Led by Cascade Pharmaceuticals, Inc · Updated on 2026-04-13
120
Participants Needed
14
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Obesity is a major risk factor for this condition. This is a Phase II clinical trial, which means we are testing the medicine to see if it works and is safe. The study will last up to 54 weeks, which is a little over a year. It includes: * A screening period of up to 2 weeks to check if you are eligible to take part. * A 36-week double-blind treatment period, where you will be randomly assigned (like flipping a coin) to receive either the study drug CS060380 or a placebo (an inactive pill that looks like the study drug). Both groups will also receive semaglutide, which is an approved medicine for weight management. Neither you nor your doctor will know which treatment you are receiving. * A 16-week open-label period, where all participants will receive CS060380. The main goal of this study is to see how the study drug affects the amount of fat in the liver, measured by a special MRI scan, and body weight. We will also monitor your overall health and safety throughout the study by checking your vital signs, doing blood and urine tests, and asking about any side effects you might experience. About 120 participants will take part in this study at almost 15 different hospitals across China, with Ruijin Hospital in Shanghai as the main study site.
CONDITIONS
Official Title
A Study of CS060380 Tablets in Patients With MASH and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years (inclusive), male or female.
- Liver fat content 10% as measured by MRI-PDFF at screening.
- BMI 30 kg/m�b2.
- Body weight change 5% during the 3 months prior to screening with only diet and exercise control.
- Glycated hemoglobin (HbA1c) <6.5% at screening.
- Fasting venous blood glucose <7 mmol/L at screening.
- Agreement to use effective contraception from screening until 3 months after the trial if of childbearing potential.
- Voluntary consent to participate and provide written informed consent.
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes, monogenic diabetes, or secondary diabetes before randomization.
- Two or more episodes of hypoglycemia within 6 months before screening.
- Impaired gastrointestinal function or diseases affecting oral drug absorption.
- Thyroid or pituitary diseases requiring certain medications.
- Obesity caused by endocrine diseases or single-gene mutations.
- Previous bariatric surgery or use of obesity treatment devices within 1 year before screening.
- Contraindications to MRI scanning.
- Blood donation within 3 months before screening or significant recent blood loss.
- Use of GLP-1 receptor agonists or weight-loss treatments within 3 months before randomization.
- Use of drugs causing significant weight gain or certain hepatotoxic drugs within 3 months before randomization.
- Use of certain hypoglycemic agents or enzyme inhibitors affecting study drug metabolism.
- Use of hepatoprotective drugs not permitted by protocol within 4 weeks before randomization.
- Anticoagulant therapy within 2 weeks before randomization.
- Heavy alcohol consumption for more than 3 consecutive months within 1 year before screening.
- Various abnormal lab values at screening including liver enzymes, hemoglobin, albumin, bilirubin, amylase, lipase, calcitonin, kidney function.
- Clinically relevant ECG abnormalities.
- Uncontrolled hypertension.
- History or presence of pancreatitis, liver cirrhosis, or other specified liver diseases.
- History or family history of certain thyroid cancers.
- Recent serious cardiovascular or cerebrovascular diseases.
- History of malignant tumor within 5 years, excluding certain skin and cervical cancers.
- History of major depression, anxiety, or other mental illnesses unsuitable for participation.
- High depression screening score or previous suicide attempt.
- Known hypersensitivity to semaglutide or related drugs.
- History of HIV, certain infections, or positive viral markers.
- Inability or unwillingness to cooperate with the trial.
- History of drug or substance abuse.
- Pregnant or lactating women or those with recent menopause without negative pregnancy test.
- Participation in other drug trials within 3 months.
- Investigator's judgment deeming participant unsuitable for trial participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Not Yet Recruiting
2
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
Not Yet Recruiting
3
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Not Yet Recruiting
4
Yichang First People's Hospital (Yichang Central People's Hospital)
Yichang, Hubei, China, 443000
Not Yet Recruiting
5
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China, 211100
Not Yet Recruiting
6
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200001
Not Yet Recruiting
7
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
8
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200080
Not Yet Recruiting
9
Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200336
Actively Recruiting
10
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
11
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
12
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
13
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
R
Rong Deng, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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