Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function

NCT07877038 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026-CP-DA168-13
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of DA-302168S, to support appropriate dosing recommendations for patients with liver impairment.

Conditions

Obesity, Overweight; T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax) of DA-302168S

  Predose up to 72 hours postdose (D1 to D4)

• Area Under the Serum Concentration Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of DA-302168S

  Predose up to 72 hours postdose (D1 to D4)

Study Arms (3)

Group A

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: DA-302168S

Group B

EXPERIMENTAL

Subjects with moderate hepatic impairment

Drug: DA-302168S

Group C

PLACEBO COMPARATOR

Subjects with normal hepatic function matched to hepatic impairment subjects

Drug: DA-302168S

Interventions

DA-302168S DRUG

Small molecule GLP-1RA tablet

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years inclusive at ICF signing; male or female. Age matching (±10 years) between normal hepatic function and hepatic impairment groups; sex matching as much as possible (±1 participant/sex).
• Screening weight/BMI: males ≥50.0 kg, females ≥45.0 kg; BMI 19.0-30.0 kg/m² inclusive. Weight matching (±10 kg) between groups.
• Women and men of childbearing potential must agree to use reliable contraception for themselves and their partners during the study and for 90 days after dosing (see Appendix 4), and must not donate sperm or eggs/oocytes for assisted reproduction.
• Able to understand the study procedures and methods; voluntarily sign the ICF; willing to strictly follow protocol requirements and complete related procedures.
• Normal hepatic function group:
• No clinically significant abnormalities in screening clinical laboratory results, vital signs, 12-lead ECG, or physical examination, as judged by the investigator.
• No known or suspected hepatic impairment at screening; screening AST and ALT \< ULN.
• Hepatic impairment group:
• Mild or moderate hepatic impairment by Child-Pugh classification due to viral hepatitis, alcoholic liver disease, non-alcoholic liver disease, schistosomal liver disease, or autoimmune hepatitis (excluding primary biliary cirrhosis).
• Stable disease with no clinically significant change within 28 days before screening (e.g., no worsening of hepatic impairment symptoms, total bilirubin or prothrombin time not worsened by \>20%). Note: Additional screening tests may be performed if needed; external test results may be accepted for preliminary comparison at the investigator's discretion.
• If receiving treatment for hepatic impairment or other comorbidities before screening, treatment must have been stable for ≥4 weeks and remain stable during the study.

You may not qualify if:

• History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or screening serum calcitonin ≥50 ng/L.
• History of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.
• History of acute gallbladder disease within 3 months before ICF signing.
• Any malignancy within 5 years before ICF signing (except basal cell carcinoma treated curatively and considered cured, and participants with prior liver cancer surgery who have been stable for ≥2 years).
• Within 1 year before ICF signing, history of serious diseases of the cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine systems (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).
• As judged by the investigator, presence at screening of dysphagia, or any disease/condition that may affect drug absorption, distribution, metabolism, or excretion, such as active inflammatory bowel disease, gastrectomy, any intestinal resection, etc.
• Participation in any clinical trial within 3 months before screening (except signing ICF only without drug or device intervention), or last dose of investigational drug in a prior trial less than 5 half-lives before screening.
• History of allergic diseases (e.g., asthma, urticaria, eczema/dermatitis) or known intolerance/allergy to glucagon-like peptide-1 receptor (GLP-1R) agonists.
• Major surgery within 1 year before screening \[defined as surgery on intracranial, thoracic, abdominal, pelvic, or limb organs causing major tissue trauma and requiring long-term recovery (e.g., organ transplantation, cardiac surgery, joint replacement)\], or planned surgery during the study; or history of liver transplantation.
• Severe hypoglycemia within 3 months before screening.
• Blood donation or significant blood loss (≥400 mL) within 3 months before screening or from screening to first dosing, or planned blood donation during the study.
• History of drug abuse within 3 years before screening (e.g., morphine, ketamine, THC acid, methamphetamine, MDMA, cocaine) or positive baseline urine drug screen.
• Within 3 months before screening, smoking \>5 cigarettes/day or habitual use of nicotine-containing products, or unable to abstain during the study.
• History of alcohol abuse within 1 year before screening (i.e., \>14 standard units/week for males, \>7 for females; 1 standard unit = 14 g alcohol, e.g., 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or positive baseline alcohol breath/blood test, or unable to abstain during the study.
• Special dietary requirements and unable to accept the standardized diet.

Sponsors & Collaborators

• Chendu DIAO Pharmaceutical Group CO., LTD.: lead

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

xiaolong qin

CONTACT

18781997925; qinxiaolong.cn@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): October 22, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share