CX11 for Obesity

Not currently recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Corxel Pharmaceuticals

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Diabetes, Heart problems, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different doses of a tablet called CX11 for weight loss in individuals who are overweight or obese. The study will also assess the safety of the tablets and their movement through the body. Participants will be divided into groups to receive various doses of CX11 or a placebo (a pill with no active ingredients) for comparison. This trial suits individuals with a BMI of 30 or higher, or a BMI between 27 and 30 if they have another weight-related health issue like high blood pressure or sleep apnea, and who have previously tried and failed to lose weight through diet and exercise. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potential new weight loss solution.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using certain weight loss medications or therapies, you must not have used them in the last 90 days. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that CX11 tablets are likely to be safe for humans?

Research shows that CX11 tablets have been tested before and have shown promising results for weight loss. In a previous study, participants taking CX11 lost about 9.7% of their body weight over 16 weeks, a significant amount. Importantly, most participants handled the treatment well.

This current trial aims to explore the safety and tolerance of different doses. Earlier findings suggest that CX11 is manageable for most people. As a Phase 2 trial, there is some confidence in the safety of CX11 because it has already passed initial safety checks. However, as with any trial, researchers will continue to monitor for side effects to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about CX11 tablets for obesity because they offer a fresh approach compared to current treatments like appetite suppressants and metabolic enhancers. CX11 works with a novel mechanism that targets specific pathways in the body to effectively manage weight. This treatment is available in multiple dosages, including 120 mg, 160 mg, and 200 mg, with both fast and slow titration options, providing flexibility and potentially more personalized treatment plans for individuals. With its innovative action and varied dosage strategies, CX11 could offer a more effective and tailored solution for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that CX11 tablets yield promising results for weight loss. In one study, 55% to 90% of participants taking CX11 lost at least 5% of their weight by week 16. In contrast, only 13% of those taking a placebo (a pill with no active ingredient) achieved the same weight loss. These findings suggest that CX11 could significantly aid weight loss in individuals who are overweight or obese. The treatment was generally well-tolerated, with most participants experiencing no major issues. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This clinical trial is for overweight or obese individuals who are looking to reduce their body weight. Participants will be selected based on specific health criteria and must not have certain medical conditions that could interfere with the study.

Inclusion Criteria

Participants must have an HbA1c level below 6.5% and fasting blood sugar levels below 126 mg/dL

Participants must 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

Exclusion Criteria

I have had an organ transplant or suffer from a severe autoimmune disease.

I have a history of pancreatitis or gallbladder disease, or thyroid issues but am stable on treatment.

My obesity is due to a hormonal or genetic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of CX11 tablets or placebo for body weight reduction

36 weeks

Visits at Day 1, Week 12, Week 26, Week 36 or at early termination

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CX11 Tablets

Trial Overview The trial is testing the effectiveness of CX11 tablets at various doses in reducing body weight compared to a placebo. It's a double-blind study, meaning neither participants nor researchers know who gets the real treatment or placebo during the trial.

How Is the Trial Designed?

Group I: 200 mg slow titration group Experimental Treatment 1 Intervention

Group II: 200 mg fast titration group Experimental Treatment 1 Intervention

Group III: 160 mg group Experimental Treatment 1 Intervention

Group IV: 120 mg group Experimental Treatment 1 Intervention

Group V: Placebo group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Corxel Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

1,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07011797

NCT07011797 | A Study to Evaluate the Efficacy and ... 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 ...

2. corxelbio.com corxelbio.com/en/press-releases/data-from-the-phase-2-clinical-trial-of-cx11vct220-in-china-presented-at-ada-2025/

Data from the Phase 2 Clinical Trial of CX11/VCT220 in ... A weight reduction of at least 5% by week 16 occurred in 55% to 90% of the participants who received CX11/VCT220, as compared to 13% who ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/corxel-trial-obesity/

Corxel to begin trial of CX11 for obesity with FDA clearance Also referred to as VCT220, CX11 was previously claimed to have demonstrated competitive weight loss results with favourable tolerability and ...

4. patlynk.com patlynk.com/trial/NCT07011797

CX11 Tablets for Weight Loss in Overweight/Obese ... Researchers will evaluate the effectiveness of the tablets by measuring changes in participants' body weight and related health indicators throughout the study.

5. globenewswire.com globenewswire.com/news-release/2025/06/23/3103347/0/en/Data-from-the-Phase-2-Clinical-Trial-of-CX11-VCT220-in-China-Presented-at-ADA-2025.html

Data from the Phase 2 Clinical Trial of CX11/VCT220 in A weight reduction of at least 5% by week 16 occurred in 55% to 90% of the participants who received CX11/VCT220, as compared to 13% who ...