Clinical trial NCT07011797: A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

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.

Exclusion Criteria

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.
* Had major surgery within the last 6 months or plan to have surgery soon.
* Significant abnormalities in kidney function, liver enzymes, blood tests, or other specified lab results.
* Positive for hepatitis B, hepatitis C, or HIV.
* Donated blood, lost a lot of blood, or received a transfusion in the last 90 days.
* Exceed weekly alcohol intake limits or have a history of drug abuse (including cannabis, its derivatives, or any cannabis-containing products; except for prescribed drug for medical purpose).
* Women who are pregnant or breastfeeding.
* Any other disease, condition, or medication that the investigator believes would interfere with the study.

Primary outcomes:
measure: Percentage change in body weight from baseline
timeFrame: At Week 26
Secondary outcomes:
measure: Proportion of participants achieving ≥ 5% body weight reduction from baseline
timeFrame: At Week 26
measure: Percentage change in body weight from baseline
timeFrame: At Week 36
measure: Proportion of participants achieving ≥ 5% body weight reduction from baseline
timeFrame: At Week 36
measure: Proportion of participants achieving ≥ 10% body weight reduction from baseline
timeFrame: At Week 26 and Week 36
measure: Change in body weight from baseline
timeFrame: At Week 26 and Week 36
measure: Change in waist circumference from baseline
timeFrame: At Week 26 and Week 36
measure: Change in body mass index (BMI) from baseline
timeFrame: At Week 26 and Week 36
measure: Number of adverse events (AEs)
timeFrame: Study duration, approximately 38 weeks
measure: Number of treatment-emergent adverse events (TEAEs)
timeFrame: Study duration, approximately 38 weeks
measure: Number of AE of special interest (AESI)
timeFrame: Study duration, approximately 38 weeks
measure: Number of serious adverse events (SAEs)
timeFrame: Study duration, approximately 38 weeks
measure: Columbia-Suicide Severity Rating Scale [C-SSRS]
timeFrame: At Day 1, Week 12, Week 26, Week 36 or at early termination (ET)
measure: Patient Health Questionnaire-9 [PHQ-9]
timeFrame: At Day 1, Week 12, Week 26, Week 36 or at ET
measure: Maximum steady-state plasma concentration (Cmax,ss)
timeFrame: Day 1 through Week 26
measure: Minimum steady-state plasma concentration (Cmin,ss)
timeFrame: Day 1 through Week 26
measure: Time to maximum steady-state plasma concentration (Tmax,ss)
timeFrame: Day 1 through Week 26
measure: Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss)
timeFrame: Day 1 through Week 26
measure: Area under the concentration-time curve over the dosing interval (AUC0-tau)
timeFrame: Day 1 through Week 26
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
state: Arizona
city: Inglewood
country: United States
facility: 310 Clinical Research - Alliance Clinical - Los Angeles
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research - Alliance Clinical - San Diego
state: California
city: Doral
country: United States
facility: Angels Clinical Research Institute - Miami
state: Florida
city: Melbourne
country: United States
facility: AES - DRS - Optimal Research Florida - Melbourne
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: North Miami Beach
country: United States
facility: Oceanic Research Group, LLC
state: Florida
city: Savannah
country: United States
facility: Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
state: Georgia
city: Thomasville
country: United States
facility: Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
state: Georgia
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
state: Indiana
city: Mankato
country: United States
facility: Mankato Clinic - East Main Street - Javara - PPDS
state: Minnesota
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS
state: Ohio
city: Dallas
country: United States
facility: Velocity Clinical Research - Dallas - PPDS
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research - Alliance Clinical - Lewisville
state: Texas
city: San Antonio
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Flourish Research - San Antonio - PPDS
state: Texas
Study officials:
References: