CX11 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, CX11, to determine its effectiveness for people with type 2 diabetes who haven't achieved good blood sugar control with metformin alone or with an SGLT2 inhibitor. Participants will be randomly assigned to one of six groups, each receiving different doses of CX11 or a placebo, to identify the most effective and safe dose. This trial may suit those who have had type 2 diabetes for at least six months, struggle to control their blood sugar levels, and have been on a stable dose of metformin for at least three months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires participants to continue taking a stable dose of metformin, with or without a stable dose of an SGLT2 inhibitor, for at least 3 months before joining. Other medications, especially those affecting blood sugar, may need to be stopped, but the protocol does not specify all details.
Is there any evidence suggesting that CX11 is likely to be safe for humans?
Research shows that CX11 is undergoing safety testing in people with type 2 diabetes. The study examines different doses, up to 200 mg, to assess tolerance. As a Phase 2 trial, earlier studies found CX11 safe enough for broader testing.
Researchers closely monitor for side effects during these trials. While specific data from earlier trials on side effects is unavailable, reaching Phase 2 suggests CX11 has demonstrated some safety. Serious safety concerns would have prevented the drug from advancing to this stage. Participants will be monitored closely for any negative effects during and after the trial, ensuring safety remains a top priority.12345Why do researchers think this study treatment might be promising for type 2 diabetes?
Researchers are excited about CX11 for Type 2 Diabetes because it offers a fresh approach to managing this condition. Unlike many standard treatments like metformin and insulin, which primarily focus on controlling blood sugar levels, CX11 might work through a novel mechanism that targets the root causes of diabetes. This could potentially lead to better long-term management of the disease. Additionally, CX11 is being tested in varying doses, allowing researchers to fine-tune its effectiveness and safety, potentially offering more personalized treatment options for patients.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes?
Research has shown that CX11 might help control blood sugar levels in people with type 2 diabetes. Studies suggest that CX11 can lower blood sugar, which is crucial for those whose current medication isn't effective enough. This trial tests CX11 in various doses up to 200 mg, and early results indicate it could be a promising option for better diabetes management. Although more data is needed, CX11 targets blood sugar control, a major challenge in type 2 diabetes.12346
Are You a Good Fit for This Trial?
Adults aged 18-75 with type 2 diabetes, not well-controlled on metformin (with or without SGLT2 inhibitors), can join this trial. They should have an HbA1c between 7.0% and 10.5%, a BMI of 23-50 kg/m², and stable body weight for the past three months. Participants must use effective birth control if they can conceive.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a randomized dose of CX11 or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CX11
Trial Overview
The study tests CX11 tablets' effectiveness and safety in managing blood sugar levels compared to a placebo over a period of 24 weeks, followed by a safety check after two weeks. It's randomized and double-blind, meaning neither participants nor staff know who gets the real drug or placebo.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corxel Pharmaceuticals
Lead Sponsor
Citations
CX11 for Type 2 Diabetes · Info for Participants
The study tests CX11 tablets' effectiveness and safety in managing blood sugar levels compared to a placebo over a period of 24 weeks, followed by a safety ...
A Study of CX11 Tablets in Patients With Type 2 Diabetes ...
This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good ...
CORXEL Receives Study May Proceed Letter from the U.S. ...
The multicenter Phase 2 trial aims to evaluate the efficacy and safety of CX11 in patients with T2DM in doses up to 200 mg ...
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ctv.veeva.com
ctv.veeva.com/study/a-study-of-cx11-tablets-in-patients-with-type-2-diabetes-mellitusA Study of CX11 Tablets in Patients With Type 2 Diabetes ...
This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good ...
Pharmacological therapies for type 2 diabetes - PubMed Central
An ideal new agent will provide durable blood glucose-lowering efficacy that is better than or similar to that of available agents, carry ...
NCT07011797 | A Study to Evaluate the Efficacy and ...
All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.
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