A Study to Evaluate the Efficacy and Safety of VCT220 in Obesity Chinese Population

NCT06569355 | Completed Phase 2

• 1 other identifier: VCT220-II-02
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to assess how VCT220 tablets affect the bodyweight when used once daily in obese or overweight adult participants Qualified participants will be randomly assigned to one of four groups using a computerized system. Participants will get VCT220 or placebo tablets for 16 weeks and will need to take tablets each morning. Participants will have 7 clinic visits and a final follow-up visit approximately 14 days after the last study intervention administration.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight

  percentage-point

  From baseline (week 1) to week 16

Secondary Outcomes (9)

• Proportion of subjects with weight decrease ≥ 5%

  From baseline (week 1) to week 16

• Absolute change in body weight

  From baseline (week 1) to week 16

• Absolute change in body mass index (BMI)

  From baseline (week 1) to week 16

• Absolute change in waist circumference

  From baseline (week 1) to week 16

• Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C)

  From baseline (week 1) to week 16

Other Outcomes (5)

• Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)

  From baseline (week 1) to week 18

• PK analysis-Minimum concentration

  From week 1 to week 12

• PK analysis-Maximum concentration

  From week 1 to week 12

Study Arms (4)

80mg dose group

EXPERIMENTAL

Participants will receive VCT220 or placebo tables in 2 weeks dose titration period and take the maintanance dose 80 mg from week 3 to week 16.

Drug: VCT220; Drug: Placebo

120mg dose group

EXPERIMENTAL

Participants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 120 mg from week 5 to week 16.

Drug: VCT220; Drug: Placebo

160mg dose group fast titration

EXPERIMENTAL

Participants will receive VCT220 or placebo tables in 4 weeks dose titration period and take the maintanance dose 160 mg from week 5 to week 16.

Drug: VCT220; Drug: Placebo

160mg dose group slow titration

EXPERIMENTAL

Participants will receive VCT220 or placebo tables in 6 weeks dose titration period and take the maintanance dose 160 mg from week 7 to week 16.

Drug: VCT220; Drug: Placebo

Interventions

VCT220 DRUG

A small molecule GLP-1R agonist tablet, orally administration, once daily

120mg dose group; 160mg dose group fast titration; 160mg dose group slow titration; 80mg dose group

Placebo DRUG

Placebo tablet

120mg dose group; 160mg dose group fast titration; 160mg dose group slow titration; 80mg dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18-75 years (inclusive) when signing the informed consent form;
• Body mass index (BMI) ≥ 28 kg/m2 with or without concomitant diseases; or BMI ≥ 24 kg/m2 and \< 28 kg/m2 combined with at least one of the following concomitant diseases: pre-diabetes (impaired fasting glucose and/or reduced glucose tolerance), hypertension, dyslipidemia, fatty liver, and obstructive sleep apnea syndrome caused by overweight (see Appendix 1 for specific definitions);
• Subjects who have undergone diet control or exercise control alone for at least 12 weeks before screening, resulting in a stable weight within 12 weeks before screening (weight change \< 5%, weight change = \[maximum weight - minimum weight\]/maximum weight; based on subjects' self-report);
• Subjects who have no fertility plan and voluntarily take effective contraceptive measures without any plans to donate sperm or eggs during the study and within 90 days after the end of study;
• Subjects who are willing and able to maintain a stable diet and exercise during the study and fill in diary cards on time; 6）Subjects who are able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.

You may not qualify if:

• Subjects with previously diagnosed obesity caused by endocrine diseases or single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, islet cell tumor, acromegaly, and hypogonadism;
• Subjects who have received bariatric surgery or treatment (except for acupuncture for weight loss, liposuction, and abdominal fat removal more than 1 year from the screening period), or plan to receive bariatric surgery to treat obesity during the study, e.g., gastric bypass surgery and gastric banding;
• Subjects who are on a weight loss program at screening and are not in the maintenance period (based on subjects' self-report);
• Subjects who have previously been diagnosed with type 1 diabetes mellitus, type 2 diabetes mellitus, or other special types of diabetes;
• Subjects who have used any GLP-1 receptor agonist (GLP-1RA), GLP-1 related multi-target agonist (e.g., GLP 1/glucose-dependent insulinotropic polypeptide \[GIP\] dual agonist and GLP 1/glucagon receptor \[GCGR\] dual agonist), or compound preparations containing GLP 1 agonist;
• Subjects who have received any of the following medications or therapies within 12 weeks before screening:
• Oral or injectable hypoglycemic medications such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium glucose cotransporter 2 (SGLT-2) inhibitors, metformin, insulin secretagogues, thiazolidinediones (TZDs), and insulin;
• Any approved or unapproved weight loss drugs (such as orlistat, lorcaserin, phentermine/topiramate, and naltrexone/bupropion) or Chinese herbal medicines, health care products, meal replacements, etc., affecting body weight;
• Use of any drugs that might significantly change body weights, including systemic (i.e., intravenous, oral, or intra-articular administration) glucocorticoids for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, and thioridazine), etc.;
• Subjects who meet any of the following criteria related to cardiac function:
• History of myocardial infarction, coronary angioplasty or bypass graft, heart valve disorders or cardiac valve prostheses, clinically significant unstable arrhythmia, unstable angina, transient ischemic attack, cerebrovascular accident, etc., within 6 months before screening;
• Class III or IV congestive cardiac failure according to New York Heart Association (NYHA) classification;
• Subjects with serious arrhythmia requiring treatment (such as long QT syndrome) and not suitable for the clinical study as assessed by the investigator;
• Poorly controlled hypertension before screening (i.e., systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Presence of clinical abnormalities (e.g., QTcF \> 450 msec, complete left bundle branch block, signs of acute or unexplained myocardial infarction, ST-segment changes suggestive of myocardial ischemia, second or third degree atrioventricular block, or serious bradyarrhythmia or tachyarrhythmia) by electrocardiography (ECG) at screening that might affect the safety of subjects or the interpretation of study results;

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 20, 2024
• First Posted: August 26, 2024
• Study Start: December 27, 2023
• Primary Completion: July 13, 2024
• Study Completion: August 1, 2024
• Last Updated: July 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)