A Study of CS060380 Tablets in Patients With MASH and Obesity

NCT07466017 | Recruiting Phase 2 DMC

• 2 other identifiers: CS060380-MASH-CN-II-032024LP01824
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief Summary

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

Obesity; Metabolic Dysfunction-associated Steatohepatitis (MASH)

Keywords

Metabolic Dysfunction-Associated Steatohepatitis; MASH; Obesity; CS060380; THR-beta agonist; Semaglutide; Phase 2 Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF)

  Percentage change in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to Week 36 of the double-blind treatment period.

  Baseline, Week 36

Secondary Outcomes (2)

• Percentage change in body weight measured by weight scale from baseline to Week 36

  Baseline, Week 36

• Percentage change in liver fat content (MRI-PDFF) from baseline to week 24

  Baseline, Weeks 24

Study Arms (2)

Placebo + Semaglutide

PLACEBO COMPARATOR

Participants receive CS060380 placebo tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.

Drug: semaglutide; Drug: Placebo

CS060380 1.0 mg + Semaglutide

EXPERIMENTAL

Participants receive CS060380 1.0 mg tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.

Drug: semaglutide; Drug: CS060380

Interventions

semaglutide DRUG

Semaglutide 1.7 mg as the background therapy for all participants

CS060380 1.0 mg + Semaglutide; Placebo + Semaglutide

CS060380 DRUG

CS060380 1.0 mg tablets for the treatment of metabolic dysfunction-associated steatohepatitis complicated with obesity

CS060380 1.0 mg + Semaglutide

Placebo DRUG

Placebo tablets matching CS060380 of double-blind control for 36 weeks

Placebo + Semaglutide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years (inclusive), male or female.
• Liver fat content ≥10% as measured by MRI-PDFF at screening.
• BMI ≥30 kg/m².
• Body weight change ≤5% during the 3 months prior to screening with only diet and exercise control (self-reported). The weight change is calculated as: (Maximum weight - Minimum weight within 3 months before screening) / Maximum weight × 100%.
• Glycated hemoglobin (HbA1c) \<6.5% at screening.
• Fasting venous blood glucose \<7 mmol/L at screening.
• All participants of childbearing potential agree to use effective physical and/or pharmacological contraceptive measures from the screening period until 3 months after the end of the trial, and have no recent plans for sperm donation, egg donation, or pregnancy.
• Voluntary consent to participate in this clinical trial and provide written informed consent.

You may not qualify if:

• Diagnosis of type 2 diabetes mellitus, type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury (e.g., post-pancreatitis diabetes), or other secondary diabetes prior to randomization.
• ≥2 episodes of hypoglycemia (blood glucose ≤2.8 mmol/L in non-diabetic patients) within 6 months before screening.
• Impaired gastrointestinal function or gastrointestinal disease that may affect the absorption of oral medications, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, or grade \>1 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea) at screening.
• Thyroid diseases including hyperthyroidism and hypothyroidism \[participants with benign thyroid lesions (e.g., thyroid nodules) may participate in this study\] or pituitary diseases, or long-term use of thyroid hormone replacement therapy, antithyroid drugs, or drugs that may affect thyroid hormone production and/or interfere with thyroid function (including but not limited to methimazole, propylthiouracil, tyrosine kinase inhibitors, lithium, iodides, and glucocorticoids, etc.).
• Previous diagnosis of obesity caused by endocrine diseases or single-gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
• Previous bariatric surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or combined procedures, etc.) or use of medical devices for obesity treatment, or planned such procedures during the trial; except for liposuction or abdominal lipectomy performed more than 1 year before screening; adjustable gastric banding with band removal more than 1 year before screening; intragastric balloon removal more than 1 year before screening.
• Blood donation within 3 months before screening, or total blood loss (excluding female physiological bleeding) due to blood donation or other reasons reaching or exceeding 400 mL within 6 months.
• Use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or compound preparations containing GLP-1 RA components within 3 months before randomization.
• Use of any approved or unapproved weight-loss drugs (e.g., orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or drugs affecting body weight (including Chinese herbal medicines), health products, meal replacements, or weight-loss acupuncture treatments within 3 months before randomization.
• Use of drugs that may cause significant weight gain: systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valproic acid and its derivatives, lithium preparations, thioridazine), etc., within 3 months before randomization.
• History of treatment for more than 1 week such as total parenteral nutrition (TPN), amiodarone, methotrexate, tetracycline, tamoxifen, estrogens in excess of hormone replacement doses, anabolic steroids, valproic acid, anticholinergic drugs, or other known hepatotoxic drugs within 3 months before randomization.
• Use of vitamin E (≥800-1000 IU/day), polyunsaturated fatty acids, ursodeoxycholic acid, fibrates, statins within 3 months before randomization, unless the participant had a stable dose for 3 months before screening, continued taking until the screening visit, and will continue the same medication regimen throughout the study participation period.
• Use of metformin, SGLT2 inhibitors, and other hypoglycemic agents within 3 months before randomization.
• Use of strong inhibitors of CYP3A enzymes, strong inducers of CYP3A enzymes, or inhibitors of P-gp or BCRP transporters that may affect the metabolism or absorption of the study drug within 14 days before randomization or at least 5 half-lives (whichever is longer), see Appendix 1.
• Use of hepatoprotective drugs not permitted by the protocol within 4 weeks before randomization or planned use during the clinical study, including silymarin, bicyclol, glycyrrhizin preparations (magnesium isoglycyrrhizinate, compound glycyrrhizin, diammonium glycyrrhizinate), except for ursodeoxycholic acid, polyene phosphatidylcholine, and reduced glutathione that have been stably used for ≥3 months before randomization.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (12)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211100, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (3)

• Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

  PMID: 33185364 BACKGROUND

• Chinese Nutrition Society Obesity Prevention and Control Branch, et al. Expert consensus on obesity prevention and control among Chinese residents [J]. J Xi'an Jiaotong Univ Med Sci. 2022;43(4):619-631.

  BACKGROUND

• Fan JG, et al. Guidelines for the prevention and treatment of metabolic-associated fatty liver disease (2024 edition). J Pract Hepatol. 2024;27(4):494-510.

  BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Weiqing Wang, Ph.D.

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Deng, MSc

CONTACT

+86-21-68030017; dengrong@cascadepharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No additional parties are masked beyond the listed roles (Participant, Care Provider, Investigator, Outcomes Assessor) during the double-blind treatment period. The masking will be lifted after the 36-week double-blind phase, and all participants will enter the open-label period with unmasked treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: this is a randomized, double-blind, placebo-controlled, parallel-group Phase II study with a 36-week double-blind treatment period followed by a 16-week open-label extension. During the double-blind period, participants receive either CS060380 1.0 mg or placebo in combination with semaglutide 1.7 mg as background therapy. In the open-label period, all participants receive CS060380. Interim analyses are planned when approximately 80% of participants complete Week 16 and Week 24 visits.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 12, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)