Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

1. mai 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 4mg CS0159
4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
Legemiddel: CS0159
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
Legemiddel: 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 komparator: CS0159 Placebo
CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
Legemiddel: 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).
Legemiddel: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage change in body weight relative to baseline
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in patient's weight relative to the baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Jiao Tong University School of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

15. mars 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MAFLD-CS0159-IIT-E

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere