Suspended

CX11 Tablets for Weight Loss in Overweight/Obese Participants

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What is being tested

CX11

+ Placebo
Drug
Other
Who is being recruted

Obesity

From 18 to 75 Years
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: June 2025

Summary

Principal SponsorCorxel Pharmaceuticals
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 17, 2025Actual date on which the first participant was enrolled.

This clinical study is focused on testing a new treatment called CX11 tablets to help reduce body weight in people who are overweight or obese. The study is important because it aims to find an effective and safe way to assist individuals struggling with weight issues, which can lead to various health problems. By comparing different doses of CX11 tablets to a placebo, researchers hope to determine which dose, if any, is most effective in aiding weight loss and improving weight-related health indicators. Participants in the study will be randomly assigned to receive either different doses of CX11 tablets or a placebo, ensuring that the study results are unbiased. The treatment will last for 36 weeks, followed by a 2-week observation period to check for any safety concerns. Researchers will evaluate the effectiveness of the tablets by measuring changes in participants' body weight and related health indicators throughout the study. Additionally, the study will assess how well participants tolerate the tablets and monitor their safety, ensuring that any risks are minimized.

Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants 
Principal SponsorCorxel Pharmaceuticals
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
250 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Obesity
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.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
5 intervention groups 

are designated in this study

20% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
Group II
Experimental
Group III
Experimental
Group IV
Experimental
Group 5
Experimental
Study Objectives
Primary Objectives

Secondary Objectives

Higher scores on the C-SSRS indicate a worse outcome, as they reflect greater severity of suicidal ideation and behavior. The scale begins at 0 and there is no single maximum value as the scale consists of multiple items that assess different aspects of suicidal ideation and behavior. Each item is scored individually, and the overall assessment is based on the combination of responses.

Higher scores on the PHQ-9 indicate a worse outcome, as they reflect more severe depression. The minimum score of the PHQ-9 is 0 and the maximum score of the PHQ-9 is 27.


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 17 locations
Suspended
AES - DRS - Synexus Clinical Research US, Inc. - Phoenix CentralPhoenix, United StatesSee the location
Suspended
310 Clinical Research - Alliance Clinical - Los AngelesInglewood, United States
Suspended
Acclaim Clinical Research - Alliance Clinical - San DiegoSan Diego, United States
Suspended
Angels Clinical Research Institute - MiamiDoral, United States

Suspended17 Study Centers