A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.
Philip N Newsome, Kristine Buchholtz, Kenneth Cusi...
https://pubmed.ncbi.nlm.nih.gov/33185364Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID07466017
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Effectiveness of CS060380 Tablets with Semaglutide in Adults With Metabolic Dysfunction-associated Steatohepatitis and Obesity
Led by Cascade Pharmaceuticals, Inc · Updated on 2026-05-20
120
Participants Needed
12
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new investigational medicine called CS060380 combined with semaglutide in adults who have metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH involves excess fat in the liver causing inflammation and damage, with obesity as a major risk factor. This Phase II clinical trial aims to assess the medicine's effects on liver fat and body weight, as well as its safety over a study period lasting up to 54 weeks. Participants will go through a screening period of up to 2 weeks to check eligibility. Then, they enter a 36-week double-blind treatment phase where they are randomly assigned to receive either CS060380 tablets or a placebo daily, alongside weekly semaglutide injections. Following this, there is a 16-week open-label period where all participants receive CS060380. About 120 adults will take part across multiple sites in China. During the study, participants will undergo MRI scans to measure liver fat, weight measurements, blood and urine tests, and vital sign monitoring. Researchers will track changes in liver fat content from baseline to Week 36 as the primary outcome. Safety is closely monitored throughout, including assessments for side effects. The study includes regular visits and evaluations over the full duration of approximately one year.
CONDITIONS
Brief Title
A Study of CS060380 Tablets in Patients With MASH and Obesity
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, male or female
- Liver fat content of at least 10% measured by MRI-PDFF at screening
- Body mass index (BMI) of 30 kg/m² or higher
- Body weight change of 5% or less during the 3 months before screening with diet and exercise only
- Glycated hemoglobin (HbA1c) below 6.5% at screening
- Fasting venous blood glucose below 7 mmol/L at screening
- Willingness to use effective contraception from screening until 3 months after the trial
- Voluntary and informed consent to participate
You will not qualify if you...
- Diagnosis of type 1 diabetes, type 2 diabetes, monogenic diabetes, or secondary diabetes before randomization
- Two or more episodes of hypoglycemia within 6 months before screening
- Severe gastrointestinal diseases or symptoms affecting oral medication absorption
- Thyroid or pituitary diseases requiring treatment that affect thyroid function
- 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, including severe claustrophobia or certain implants
- Recent blood donation or significant blood loss
- Use of GLP-1 receptor agonists or weight-loss drugs within 3 months before randomization
- Use of drugs causing significant weight gain or known hepatotoxic drugs within 3 months before randomization
- Uncontrolled hypertension or significant heart, liver, or pancreas diseases
- History of certain cancers or recent major depression or anxiety
- Known hypersensitivity to semaglutide or related drugs
- Positive tests for HIV, hepatitis B or C, or syphilis unless stable
- Pregnant or lactating women; females of childbearing potential must have a negative pregnancy test
- Participation in other drug trials within 3 months
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 36 weeks
Participants receive CS060380 tablets or placebo daily along with semaglutide weekly during the double-blind treatment period.
Weekly visits for 36 weeks
Treatment
Duration - 16 weeks
All participants receive open-label CS060380 tablets daily along with semaglutide weekly during the open-label period.
Regular visits during open-label period
Trial Site Locations
Total: 12 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
2
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
Actively Recruiting
3
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Actively Recruiting
4
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China, 211100
Actively Recruiting
5
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
6
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
7
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
8
Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200336
Actively Recruiting
9
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
10
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
11
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
12
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
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Research Team
R
Rong Deng, MSc
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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