A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants

NCT07011797 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CX11201
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 17

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study:

• To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo.
• To compare the changes of effects in weight and weight-related indicators at the visit time points.
• To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants.
• To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants. Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.

Conditions

Obesity

Keywords

Overweight/Obese participants; Changes in weight and weight related indicators; Safety and Tolerability of IP; Efficacy, Safety, Tolerability and PK characteristic of different doses; Percentage change in weight; Body weight reduction; Change in waist circumference; Change in Body Mass Index; Pharmacokinetic analysis; Columbia-Suicide Severity Rating Scale; Patient Health Questionnaire-9; Weight loss

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight from baseline

  At Week 26

Secondary Outcomes (18)

• Proportion of participants achieving ≥ 5% body weight reduction from baseline

  At Week 26

• Percentage change in body weight from baseline

  At Week 36

• Proportion of participants achieving ≥ 5% body weight reduction from baseline

  At Week 36

• Proportion of participants achieving ≥ 10% body weight reduction from baseline

  At Week 26 and Week 36

• Change in body weight from baseline

  At Week 26 and Week 36

Study Arms (5)

Placebo group

PLACEBO COMPARATOR

Other: Placebo

120 mg group

EXPERIMENTAL

Drug: CX11

160 mg group

EXPERIMENTAL

Drug: CX11

200 mg fast titration group

EXPERIMENTAL

Drug: CX11

200 mg slow titration group

EXPERIMENTAL

Drug: CX11

Interventions

CX11 DRUG

CX11 tablets administered orally once daily (QD) with meals

Also known as: VCT220

120 mg group; 160 mg group; 200 mg fast titration group; 200 mg slow titration group

Placebo OTHER

Matching placebo tablets administered orally once daily (QD) with meals

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:

• Participants who meet all of the following criteria will be eligible to participate in this study:
• Between 18 and 75 years old. Both men and women can participate, but women may make up to 70% of the participants.
• BMI of 30 or higher, or a BMI between 27 and 30 with at least one related health condition such as prediabetes, high blood pressure, abnormal cholesterol levels, fatty liver, or sleep apnea due to being overweight.
• HbA1c level below 6.5% and fasting blood sugar levels below 126 mg/dL.
• Have tried and failed to lose weight through diet and exercise at least once before the study and must have had a stable body weight (less than a 5% change) in the 90 days before the study.
• Participants and their partners must not plan to become pregnant or donate sperm/eggs during the study and for 90 days after. They must agree to use effective contraception for at least 6 months prior to screening and continue their chosen contraception method throughout the study. Women who could become pregnant must have a negative pregnancy test 24 hours before the first dose of study drug.
• Willing to maintain a stable diet and exercise routine during the study and keep a diary of their activities.
• Understand the study procedures, be willing to follow the study rules strictly, and sign a consent form voluntarily.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from this study:
• Known or suspected hypersensitivity to GLP-1 receptor agonists or similar products.
• Took part in another clinical study and received treatment within the last 90 days or within 5 drug elimination half-lives.
• Any type of diabetes.
• Obesity caused by hormonal or genetic issues such as thyroid problems, Cushing's syndrome, or other specific conditions.
• Have had or plan to have obesity treatment surgery or use weight loss devices, with some exceptions if done over a year ago.
• Have used certain medications or therapies for weight loss or conditions affecting weight, including GLP-1 receptor agonists and other related drugs, within the last 90 days.
• Recent serious heart problems, uncontrolled high blood pressure, or certain ECG abnormalities.
• History of pancreatitis, gallbladder disease (except for those treated with cholecystectomy), or evidence of hypothyroidism (except for participants who have normal thyroid function at screening and have been on a stable dose thyroid replacement for at least 90 days and are expected to maintain a stable dose during the study) or hyperthyroidism or thyrotoxicosis.
• History of cancer in the last 5 years, except for localized basal or squamous skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer.
• Serious gastrointestinal diseases or surgeries that affect drug absorption.
• Active liver disease, excluding nonalcoholic fatty liver disease.
• Other serious health conditions that could increase study risk or make participation inappropriate, including certain psychiatric disorders.
• Recent history of unexplained fainting or family history of long QT syndrome or sudden death.
• History of organ transplant or severe autoimmune diseases.

Sponsors & Collaborators

• Corxel Pharmaceuticals: lead

Study Sites (17)

AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central

Phoenix, Arizona, 85020-4327, United States

Location

310 Clinical Research - Alliance Clinical - Los Angeles

Inglewood, California, 90301, United States

Location

Acclaim Clinical Research - Alliance Clinical - San Diego

San Diego, California, 92120, United States

Location

Angels Clinical Research Institute - Miami

Doral, Florida, 33122-1713, United States

Location

AES - DRS - Optimal Research Florida - Melbourne

Melbourne, Florida, 32934-8172, United States

Location

Angels Clinical Research Institute

Miami, Florida, 33126, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014-2266, United States

Location

Oceanic Research Group, LLC

North Miami Beach, Florida, 33169, United States

Location

Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

Savannah, Georgia, 31406-3928, United States

Location

Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS

Thomasville, Georgia, 31792-6618, United States

Location

Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS

Valparaiso, Indiana, 46383, United States

Location

Mankato Clinic - East Main Street - Javara - PPDS

Mankato, Minnesota, 56001, United States

Location

Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS

Cincinnati, Ohio, 45246-2316, United States

Location

Velocity Clinical Research - Dallas - PPDS

Dallas, Texas, 75230, United States

Location

Epic Clinical Research - Alliance Clinical - Lewisville

Lewisville, Texas, 75057, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

San Antonio, Texas, 78229, United States

Location

Flourish Research - San Antonio - PPDS

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 17, 2025
• Primary Completion: March 23, 2026
• Study Completion: April 6, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (17)