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

ConditionsType 2 DiabetesObesityNon-alcoholic Fatty Liver Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CS0159

    Drug

    The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).

  • CS0159 placebo

    Drug

    The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).

  • Semaglutide

    Drug

    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).

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 4mg CS0159Active comparator 2 interventions
Group B: CS0159 PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage change in body weight relative to baseline

Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.

Time frame
Baseline to 12 weeks
2

Changes in energy expenditure

The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Change in patient's weight relative to the baseline

Evaluation of the change in patient's weight relative to the baseline after 12 weeks with CS0159

Time frame
Baseline to 12 weeks
2

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Evaluate the safety and tolerability of CS0159 combined with semaglutide during a 12-week treatment period

Time frame
Baseline to 12 weeks
3

Change in patient's glucose oxidation

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).

Time frame
Baseline to 12 weeks
4

Change in patient's lipid oxidation

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).

Time frame
Baseline to 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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