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Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM

1 mei 2026 bijgewerkt door: Wang Weiqing, Shanghai Jiao Tong University School of Medicine

A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM

This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MAFLD patients with obesity and T2DM. Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 weeks.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 1. Age≥18 and ≤65 years, male or female.
  • 2. MRI-PDFF ≥10% within 3 months prior to randomized.
  • 3. Diagnosis of T2DM.
  • 4. HbA1c: 7.0%-10.5%.
  • 5. FPG: 7.0-13.3 mmol/L.
  • 6. BMI: 30-45 kg/m2.
  • 7. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.
  • 8. Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.
  • 9. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.

Exclusion Criteria:

  • 1. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance<60 mL/min, PLT<100×10^9/L, INR >1.3, ALB <3.5 g/dL.
  • 2. Use of glucose-lowering medication in the 3 months prior to randomization.
  • 3. Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.
  • 4. History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.
  • 5. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
  • 6. Subjects with a history of severe pruritus.
  • 7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
  • 8. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
  • 9. History of acute or chronic pancreatitis.
  • 10. Subjects with Child-Pugh class B or C grade cirrhosis.
  • 11. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
  • 12. Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.
  • 13. Diseases that interfere with the absorption, distribution, metabolism or excretion.
  • 14. Gastrointestinal diseases that affect food digestion and absorption.
  • 15. Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.
  • 16. History of malignant tumors within the first 5 years of randomization.
  • 17. Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.
  • 18. Drug abuse or alcohol abuse within the first 6 months of randomization.
  • 19. Poor blood pressure control.
  • 20. Mental illness, epilepsy.
  • 21. Patients with uncontrollable severe infectious diseases before randomization.
  • 22. Pregnant, planned pregnancy or breastfeeding.
  • 23. Participated in other clinical trials in the first three months of randomization.
  • 24. Any condition that in the judgement of the researcher precludes participation.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 4mg CS0159
4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
Geneesmiddel: CS0159
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
Geneesmiddel: Semaglutide
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).
Placebo-vergelijker: CS0159 Placebo
CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
Geneesmiddel: Semaglutide
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).
Geneesmiddel: CS0159 placebo
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage change in body weight relative to baseline
Tijdsspanne: Baseline to 12 weeks
Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.
Baseline to 12 weeks
Changes in energy expenditure
Tijdsspanne: Baseline to 12 weeks
The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).
Baseline to 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in patient's weight relative to the baseline
Tijdsspanne: Baseline to 12 weeks
Evaluation of the change in patient's weight relative to the baseline after 12 weeks with CS0159
Baseline to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Tijdsspanne: Baseline to 12 weeks
Evaluate the safety and tolerability of CS0159 combined with semaglutide during a 12-week treatment period
Baseline to 12 weeks
Change in patient's glucose oxidation
Tijdsspanne: Baseline to 12 weeks
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
Baseline to 12 weeks
Change in patient's lipid oxidation
Tijdsspanne: Baseline to 12 weeks
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
Baseline to 12 weeks
Percentage change in HbA1c relative to baseline
Tijdsspanne: Baseline to 12 weeks
Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 12 weeks of treatment.
Baseline to 12 weeks
Changes relative to baseline in BMI
Tijdsspanne: Baseline to 12 weeks
Changes in body mass index (BMI) relative to baseline after 12 weeks of administration
Baseline to 12 weeks
Changes relative to baseline in body composition
Tijdsspanne: Baseline to 12 weeks
Changes in body composition analysis relative to baseline after 12 weeks of administration
Baseline to 12 weeks
Changes relative to baseline in waist circumference
Tijdsspanne: Baseline to 12 weeks
Changes in waist circumference relative to baseline after 12 weeks of administration
Baseline to 12 weeks
Changes relative to baseline in waist to hip ratio (WHR)
Tijdsspanne: Baseline to 12 weeks
Changes in waist to hip ratio (WHR) relative to baseline after 12 weeks of administration
Baseline to 12 weeks
Changes relative to baseline in serum liver function parameters
Tijdsspanne: Baseline to 12 weeks
including alanine aminotransferase, aspartate aminotransferase, glutamyltransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, total protein, albumin, and total bile acid.
Baseline to 12 weeks
Changes relative to baseline in serum lipid profile
Tijdsspanne: Baseline to 12 weeks
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
Baseline to 12 weeks
Changes relative to baseline in plasma glucose levels
Tijdsspanne: Baseline to 12 weeks
including fasting plasma glucose and 2-hour post-prandial plasma glucose
Baseline to 12 weeks
Changes relative to baseline in serum insulin levels
Tijdsspanne: Baseline to 12 weeks
including fasting serum insulin and 2-hour post-prandial serum insulin
Baseline to 12 weeks
Changes in peripheral blood metabolomics and proteomics relative to baseline
Tijdsspanne: Baseline to 12 weeks
Changes in peripheral blood metabolomics and proteomics relative to baseline after 12 weeks of administration
Baseline to 12 weeks
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline
Tijdsspanne: Baseline to 12 weeks
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline after 12 weeks of administration
Baseline to 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Jiao Tong University School of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

30 november 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

15 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 mei 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

1 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MAFLD-CS0159-IIT-E

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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