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

Corxel Pharmaceuticals

Status and phase: Invitation-only; Phase 2

Conditions: Obesity

Treatments: Other: Placebo; Drug: CX11

Study type: Interventional

Funder types: Industry

Identifiers

NCT07011797

CX11201

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 5 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Treatment:

Other: Placebo

120 mg group

Experimental group

Treatment:

Drug: CX11

160 mg group

Experimental group

Treatment:

Drug: CX11

200 mg fast titration group

Experimental group

Treatment:

Drug: CX11

200 mg slow titration group

Experimental group

Treatment:

Drug: CX11