A Study Evulating DA-302168S Tablets in Overweight/Obese Subjects

NCT06541730 | Completed Phase 1

• 1 other identifier: 2024-CP-DA168-05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.

  Through study completion, an average of 49 days.

Secondary Outcomes (8)

• Cmax

  Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.

• Tmax

  Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.

• AUC0-t

  Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.

• Cmin

  Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.

• PTR

  Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.

Study Arms (2)

DA-302168S

EXPERIMENTAL

Drug: DA-302168S

Placebo of DA-302168S

PLACEBO COMPARATOR

Drug: Placebo of DA-302168S

Interventions

DA-302168S DRUG

Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude.

DA-302168S

Placebo of DA-302168S DRUG

Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude.

Placebo of DA-302168S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18\~60 years old, male and female.
• Weight: male ≥50 kg, female ≥45 kg, body mass index (BMI) in the range of 24.0 to 35.0 kg/m2.
• Stable weight in the 3 months prior to screening (self-reported weight change less than 5%).
• Subject and his or her spouse or partner did not plan to become pregnant or plan to donate sperm or ovums from 14 days prior to screening to 3 months after the last dose, and agreed to use at least one acceptable method of effective contraception.
• Written informed consent prior to any study specific procedures.

You may not qualify if:

• Subjects with secondary obesity, such as obesity caused by metabolic diseases (such as Cushing's syndrome, decreased thyroid function, etc.) or drug-induced obesity (such as glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.)
• Subjects with clinically significant cardiovascular and cerebrovascular diseases, including a history of angina pectoris, myocardial infarction, stroke or severe peripheral arterial circulation disorder, or transient ischemic attack within 1 year before signing the ICF; There are risk factors for tip torsion ventricular tachycardia. The presence of untreated severe arrhythmias, such as sick sinus syndrome, second or third degree atrioventricular block; New York Heart Association Heart Function Class II-IV heart failure.
• Previous history or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2;
• Subjects with acute pancreatitis or acute cholecystitis within 3 months before signing the ICF, or with chronic pancreatitis in the past, a history of symptomatic gallbladder (such as multiple gallstones, etc.), or a history of pancreatic injury and other high-risk factors that may lead to pancreatitis;
• Had any malignancy within 5 years prior to signing the ICF (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
• The presence of concomitant diseases, including but not limited to diseases of the respiratory system, digestive system, nervous system, genitourinary system, blood system, endocrine system, etc. that are determined by the investigator to affect the safety of the subject or the findings of the study;
• Those who had previously undergone weight loss surgery (excluding acupuncture for weight loss, liposuction and abdominal fat removal 1 year before screening) or planned to undergo surgery for obesity during the study period, such as gastric bypass or gastric banding;
• Subjects who have experienced severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year) in the past;
• Subjects who have a history of specific allergies (asthma, urticaria, eczema, etc.) or allergies, or are allergic to any component of the investigatory drug or preparation, or are allergic to other GLP-1RA drugs or drugs that have a mechanism of activating GLP-1 receptor;
• HbA1c≥6.5%, or fasting blood glucose ≥7.0 mmol/L or ≤3.9 mmol/L at screening period, or previously diagnosed with type 1 diabetes, type 2 diabetes, or other specific type of diabetes;
• Subjects with a history of thyroid dysfunction who still need drug therapy at screening, or abnormal thyroid function results at screening that are clinically significant;
• A history of moderate to severe depression, anxiety disorder, or a history of serious mental illness, such as schizophrenia or bipolar disorder; Or previous suicidal tendencies or behaviors;
• A history of dysphagia or any gastrointestinal disorder that affects drug absorption (as determined by the investigator);
• Subjects who cannot tolerate venipunction, have a history of needle fainting and blood fainting;
• Lactose intolerant;

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Hu, Doctor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Yi Jun Du, Doctor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: August 30, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)