Obesity
Conditions
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
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.
Interventions
DRUGCX11
CX11 tablets administered orally once daily (QD) with meals
OTHERPlacebo
Matching placebo tablets administered orally once daily (QD) with meals
Sponsors
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline | At Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ≥ 10% body weight reduction from baseline | At Week 26 and Week 36 | — |
| Change in body weight from baseline | At Week 26 and Week 36 | — |
| Change in waist circumference from baseline | At Week 26 and Week 36 | — |
| Change in body mass index (BMI) from baseline | At Week 26 and Week 36 | — |
| Number of adverse events (AEs) | Study duration, approximately 38 weeks | — |
| Number of treatment-emergent adverse events (TEAEs) | Study duration, approximately 38 weeks | — |
| Number of AE of special interest (AESI) | Study duration, approximately 38 weeks | — |
| Number of serious adverse events (SAEs) | Study duration, approximately 38 weeks | — |
| Columbia-Suicide Severity Rating Scale [C-SSRS] | At Day 1, Week 12, Week 26, Week 36 or at early termination (ET) | 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. |
| Patient Health Questionnaire-9 [PHQ-9] | At Day 1, Week 12, Week 26, Week 36 or at ET | 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. |
| Maximum steady-state plasma concentration (Cmax,ss) | Day 1 through Week 26 | — |
| Minimum steady-state plasma concentration (Cmin,ss) | Day 1 through Week 26 | — |
| Time to maximum steady-state plasma concentration (Tmax,ss) | Day 1 through Week 26 | — |
| Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss) | Day 1 through Week 26 | — |
| Area under the concentration-time curve over the dosing interval (AUC0-tau) | Day 1 through Week 26 | — |
Countries
United States
Outcome results
None listed