ObesityPhase 2NCT07011797
A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
A Phase 2 study testing CX11 in people with Obesity, run by Corxel Pharmaceuticals at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- CX11
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 17 sitesUnited States
- Study dates
- 17 Jun 2025to 9 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS
Cincinnati, Ohio, 45246-2316
Velocity Clinical Research - Dallas - PPDS
Dallas, Texas, 75230
Angels Clinical Research Institute - Miami
Doral, Florida, 33122-1713
310 Clinical Research - Alliance Clinical - Los Angeles
Inglewood, California, 90301
Epic Clinical Research - Alliance Clinical - Lewisville
Lewisville, Texas, 75057
Mankato Clinic - East Main Street - Javara - PPDS
Mankato, Minnesota, 56001
AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, 32934-8172
Angels Clinical Research Institute
Miami, Florida, 33126
Palm Springs Community Health Center
Miami Lakes, Florida, 33014-2266
Oceanic Research Group, LLC
North Miami Beach, Florida, 33169
AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
Phoenix, Arizona, 85020-4327
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, 78229
Flourish Research - San Antonio - PPDS
San Antonio, Texas, 78229
Acclaim Clinical Research - Alliance Clinical - San Diego
San Diego, California, 92120
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, 31406-3928
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia, 31792-6618
Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
Valparaiso, Indiana, 46383
About this study
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
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.
- Conditions
- Obesity
- Being tested
- CX11, Placebo
- 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
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX11Drug
Also called VCT220
CX11 tablets administered orally once daily (QD) with meals
PlaceboOther
Matching placebo tablets administered orally once daily (QD) with meals
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
| 120 mg group | Experimental | Not described Receives: Drug: CX11 |
| 160 mg group | Experimental | Not described Receives: Drug: CX11 |
| 200 mg fast titration group | Experimental | Not described Receives: Drug: CX11 |
| 200 mg slow titration group | Experimental | Not described Receives: Drug: CX11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline
Measured: At Week 26
Secondary outcomes (18)
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Measured: At Week 26
Percentage change in body weight from baseline
Measured: At Week 36
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Measured: At Week 36
Proportion of participants achieving ≥ 10% body weight reduction from baseline
Measured: At Week 26 and Week 36
Change in body weight from baseline
Measured: At Week 26 and Week 36
Change in waist circumference from baseline
Measured: At Week 26 and Week 36
Change in body mass index (BMI) from baseline
Measured: At Week 26 and Week 36
Number of adverse events (AEs)
Measured: Study duration, approximately 38 weeks
Number of treatment-emergent adverse events (TEAEs)
Measured: Study duration, approximately 38 weeks
Number of AE of special interest (AESI)
Measured: Study duration, approximately 38 weeks
Number of serious adverse events (SAEs)
Measured: Study duration, approximately 38 weeks
Columbia-Suicide Severity Rating Scale [C-SSRS]
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.
Measured: At Day 1, Week 12, Week 26, Week 36 or at early termination (ET)
Patient Health Questionnaire-9 [PHQ-9]
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.
Measured: At Day 1, Week 12, Week 26, Week 36 or at ET
Maximum steady-state plasma concentration (Cmax,ss)
Measured: Day 1 through Week 26
Minimum steady-state plasma concentration (Cmin,ss)
Measured: Day 1 through Week 26
Time to maximum steady-state plasma concentration (Tmax,ss)
Measured: Day 1 through Week 26
Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss)
Measured: Day 1 through Week 26
Area under the concentration-time curve over the dosing interval (AUC0-tau)
Measured: Day 1 through Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start17 Jun 2025
- Primary completion23 Mar 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011797
- Sponsor's protocol ID
- CX11201
- Status last verified
- May 2026
- First submitted
- 2 Jun 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07011797
- Acronym / sponsor ID
- CX11201
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo |
| 120 mg group | Experimental | Drug: CX11 |
| 160 mg group | Experimental | Drug: CX11 |
| 200 mg fast titration group | Experimental | Drug: CX11 |
| 200 mg slow titration group | Experimental | Drug: CX11 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX11Also: VCT220CX11 tablets administered orally once daily (QD) with meals | Drug | 120 mg group, 160 mg group, 200 mg fast titration group, 200 mg slow titration group |
| PlaceboMatching placebo tablets administered orally once daily (QD) with meals | Other | Placebo group |
Primary outcome
Percentage change in body weight from baseline
Time frame: At Week 26
18 secondary outcomes
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Time frame: At Week 26
Percentage change in body weight from baseline
Time frame: At Week 36
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Time frame: At Week 36
Proportion of participants achieving ≥ 10% body weight reduction from baseline
Time frame: At Week 26 and Week 36
Change in body weight from baseline
Time frame: At Week 26 and Week 36
Change in waist circumference from baseline
Time frame: At Week 26 and Week 36
Change in body mass index (BMI) from baseline
Time frame: At Week 26 and Week 36
Number of adverse events (AEs)
Time frame: Study duration, approximately 38 weeks
Number of treatment-emergent adverse events (TEAEs)
Time frame: Study duration, approximately 38 weeks
Number of AE of special interest (AESI)
Time frame: Study duration, approximately 38 weeks
Number of serious adverse events (SAEs)
Time frame: Study duration, approximately 38 weeks
Columbia-Suicide Severity Rating Scale [C-SSRS]
Time frame: At Day 1, Week 12, Week 26, Week 36 or at early termination (ET)
Patient Health Questionnaire-9 [PHQ-9]
Time frame: At Day 1, Week 12, Week 26, Week 36 or at ET
Maximum steady-state plasma concentration (Cmax,ss)
Time frame: Day 1 through Week 26
Minimum steady-state plasma concentration (Cmin,ss)
Time frame: Day 1 through Week 26
Time to maximum steady-state plasma concentration (Tmax,ss)
Time frame: Day 1 through Week 26
Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss)
Time frame: Day 1 through Week 26
Area under the concentration-time curve over the dosing interval (AUC0-tau)
Time frame: Day 1 through Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX11 in people with Obesity, run by Corxel Pharmaceuticals at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline (time frame: At Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.