A Research Study of VCT220 in Adult Chinese Participants With Obesity

NCT06939296 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: VCT220-III-01
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Percentage change from baseline in body weight

  From baseline to week 34

• The proportion of subjects with a body weight reduction ≥5% from baseline

  From baseline to week 34

Secondary Outcomes (13)

• Percentage change from baseline in waist circumference

  From baseline to week 34

• Percentage change from baseline in body weight

  From baseline to week 52

• The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%

  From baseline to week 34 and week 52

• The proportion of subjects with a body weight reduction of ≥5% from baseline

  From baseline to week 52

• Percentage change from baseline in body mass index (BMI)

  From baseline to week 52

Other Outcomes (2)

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

  From week 0 to week 56

• Change from baseline in liver fat content measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)

  From baseline to week 52

Study Arms (3)

High dose group

EXPERIMENTAL

Participants will receive VCT220 orally, once daily, titrate during 8 weeks and maintain at a high dose.

Drug: VCT220

Moderate dose group

EXPERIMENTAL

Participants will receive VCT220 orally, once daily, titrate during 6 weeks and maintain at a moderate dose.

Drug: VCT220

Placebo group

PLACEBO COMPARATOR

Participants will receive placebo tablets orally, once daily

Drug: Placebo

Interventions

VCT220 DRUG

A small molecule GLP-1R drug, film coated tablet

Also known as: CX11

High dose group; Moderate dose group

Placebo DRUG

Placebo tablets

Placebo 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:

• Age 18-75 years, both male and female;
• At screening, BMI ≥ 28 kg/m² or 24 kg/m² ≤ BMI \< 28 kg/m² with at least one of the following conditions:
• Comorbid prediabetes (impaired fasting glucose and/or abnormal glucose tolerance), hypertension, dyslipidemia, or fatty liver (within the past 6 months prior to screening);
• Comorbid weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases);
• Obesity-related shortness of breath or obstructive sleep apnea syndrome;
• Weight change during the past 3 months due to diet and exercise control should not exceed 5% (self-reported); weight change calculation formula: (highest weight - lowest weight in the past 3 months) / highest weight \* 100%;
• Willing and able to maintain a stable diet and exercise regimen throughout the study;
• Fully understands the purpose of the study, able to communicate well with the investigator, can comprehend and comply with the requirements of this study, and is willing to sign the informed consent form

You may not qualify if:

• Patients with type 1, type 2, or other types of diabetes.
• A history of endocrine diseases or obesity caused by single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
• A history of weight-loss surgery (except for liposuction performed more than 1 year ago) or plans to undergo weight-loss surgery, use weight-loss devices, or medical equipment during the study.
• Has used any of the following medications or treatments:
• Has previously used any GLP-1 receptor agonists (GLP-1RAs), GLP-1-related multi-target agonists (such as GLP-1/glucose-dependent insulinotropic peptide \[GIP\] dual receptor agonists, GLP-1 receptor/glucagon receptor \[GCGR\] dual agonists, GLP-1/GIP/glucagon \[GCG\] triple receptor agonists, etc.), or combination formulations containing GLP-1RAs (such as exenatide, liraglutide, semaglutide, benaglutide, etc.);
• Within the past 6 months prior to screening, has used any approved or unapproved weight-loss medications other than GLP-1 receptor agonists (GLP-1RAs) and GLP-1-related multi-target agonists (such as orlistat, phentermine/topiramate, naltrexone/bupropion, etc.), or weight-affecting herbal medicines, supplements, meal replacements, etc.;
• Within the past 3 months prior to screening, has used any antidiabetic medications, such as metformin, α-glucosidase inhibitors, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), etc.;
• Within the past 3 months prior to screening, has used any medications that may cause significant weight gain, including systemic corticosteroid treatment for more than 1 week, tricyclic antidepressants, antipsychotic or anticonvulsant medications (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts, methyldopa, etc.).

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital （ There are multiple sites in this clinical trial）

Beijing, Beijing Municipality, 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 22, 2025
• Study Start: December 24, 2024
• Primary Completion: November 25, 2025
• Study Completion: March 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-04

Locations

CN (1)