New combo pill aims to tackle fatty liver, obesity, and diabetes at once
NCT ID NCT07570810
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether adding an experimental drug (CS0159) to a standard diabetes medication (semaglutide) can help people with fatty liver disease, obesity, and type 2 diabetes lose weight and improve their health. About 30 adults will take the combination or a placebo for 12 weeks. The main goals are to see how much weight they lose and how their body uses energy, while also checking for side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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