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New combo pill could shrink fatty liver and shed pounds

NCT ID NCT07466017

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests an experimental drug called CS060380, taken with the weight-loss drug semaglutide, in adults with both fatty liver disease (MASH) and obesity. About 120 participants will be randomly assigned to get either CS060380 or a placebo for 36 weeks, then everyone gets CS060380 for 16 more weeks. The goal is to see if the drug reduces liver fat and body weight safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CS060380 (an experimental drug) plus semaglutide (a weight management drug)
What this could lead to
If it works, this could lead to a new treatment that reduces liver fat and body weight in people with MASH and obesity.
What could go wrong
This is an early Phase 2 trial with only 120 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

130 people

The number who actually took part.

Started

Apr 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 with reproductive capacity agreed to take effective contraceptive measures for themselves and their partners from the screening period until the end of the trial (physical contraception was used before and during the trial, and only drug contraception was used when necessary after or during the trial), and there were no recent plans for sperm donation, egg donation, or childbearing. * Voluntary consent to participate in this clinical trial and provide written informed consent. Exclusion Criteria: 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. * Any contraindication to MRI scanning (including but not limited to severe claustrophobia, coronary artery stents, coronary implant devices, waist circumference exceeding scanner capacity making MRI-PDFF examination impossible). If coronary stents or other devices do not interfere with the function of the MRI machine, the investigator may decide at their discretion whether to allow inclusion. * 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. * Anticoagulant therapy within 2 weeks before randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.). * History of heavy alcohol consumption for more than 3 consecutive months within 1 year before screening. Note: Heavy alcohol consumption is defined as an average weekly alcohol intake of more than approximately 7 standard drinks for women and more than approximately 14 standard drinks for men. One standard drink is defined as any beverage containing 14g of pure alcohol, such as 12 oz/360 ml of beer (5% alcohol), 8 oz/240 ml of malt liquor (7% alcohol), 5 oz/150 ml of wine (12% alcohol), 1.5 oz/45 ml of spirits (40% alcohol). * Hemoglobin ≤90 g/L at screening. * ALT ≥2.5×ULN at screening. * AST ≥2.5×ULN at screening. * Serum albumin (ALB) \<35 g/L at screening. * International normalized ratio (INR) \>1.2 at screening. * Total bilirubin (TBil) \>1.2×ULN at screening (except for Gilbert's syndrome). * Serum amylase or lipase ≥3×ULN at screening. * Calcitonin ≥50 ng/L at screening. * Estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73m² at screening. * Clinically relevant abnormalities on 12-lead ECG that, in the investigator's judgment, may affect participant safety or the interpretation of study results, such as: at screening, QTcF interval corrected by Fridericia \>450 ms (males) or \>470 ms (females) \[Fridericia formula: QTcF = QT/(RR\^0.33)\]. * Uncontrolled hypertension: sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg. * Previous history of acute or chronic pancreatitis, or acute or chronic pancreatitis at screening. * History of liver cirrhosis (e.g., the participant has undergone liver histopathological examination showing cirrhosis, or endoscopic examination suggesting esophageal and gastric varices). * Including other liver diseases or liver disease history, such as: PBC, PSC, alcoholic liver disease, definite autoimmune liver disease or coexisting hepatitis, drug-induced liver injury, suspected or confirmed Gilbert syndrome or Wilson disease; homozygous α-1-antitrypsin deficiency; all primary iron overload diseases (including but not limited to hereditary hemochromatosis, non-hemochromatosis primary iron overload such as ceruloplasminemia, congenital transferrin deficiency syndrome, etc.) or some secondary iron overload diseases (including but not limited to transfusion-dependent iron overload, ineffective hematopoiesis-related iron overload such as MDS and sideroblastic anemia, copper-induced Parkinsonism secondary iron overload, long-term excessive iron metabolism intake, etc.), but MASH metabolism-related iron overload is excluded; drug-induced liver disease; known biliary obstruction; suspected or confirmed liver cancer or any other form of liver disease except alcoholic liver steatosis and MASH (except for those related to alcohol), known biliary obstruction, suspected or confirmed liver cancer. * Patients with multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, or a family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * History of the following cardiovascular and cerebrovascular diseases within 6 months before screening: decompensated cardiac insufficiency (NYHA class III or IV), arrhythmia requiring treatment, unstable angina or myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, stroke (ischemic or hemorrhagic) or transient ischemic attack. * History of malignant tumor within 5 years (excluding clinically cured cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin). * History of major depression or anxiety disorder within 2 years before screening, or current diagnosis of other mental illnesses (e.g., schizophrenia, bipolar disorder) that, in the investigator's assessment, are not suitable for participation in this trial. * PHQ-9 questionnaire (Depression Screening Scale) score ≥15 at screening. * Previous suicide attempt or suicidal behavior. * Known hypersensitivity to any ingredient in semaglutide injection or to other GLP-1 RA drugs or drugs with GLP-1 receptor agonist mechanism. * History of human immunodeficiency virus (HIV) infection at screening; history of Treponema pallidum (TP) infection (except those with stable conditions judged by the investigator as suitable for inclusion in this trial); positive for hepatitis B surface antigen (HBsAg) \[except those with HBV-DNA results below the lower limit of detection\], positive for hepatitis C virus antibody. * Unwilling to cooperate, or unable to cooperate, or incapable of completing the clinical trial. * Suspected or confirmed history of drug or substance abuse. * Pregnant or lactating women; female participants of childbearing potential or those with menopause less than 12 months must have a negative pregnancy test during the screening period. * Participation in other drug clinical trials within the last 3 months. * In the investigator's judgment, the participant is not suitable to participate in this clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100, China

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200001, China

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150, China

  • Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200336, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014, China

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