CX11 for Type 2 Diabetes

Not yet recruiting at 45 trial locations
SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Corxel Pharmaceuticals
Must be taking: Metformin, SGLT2 inhibitors
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days.

The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug.

After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

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

I am between 18 and 75 years old.
I have been diagnosed with type 2 diabetes for at least 6 months.
My weight has been stable for the last 3 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a randomized dose of CX11 or placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

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

Group I: 80 mg groupExperimental Treatment1 Intervention
Group II: 40 mg groupExperimental Treatment1 Intervention
Group III: 200 mg groupExperimental Treatment1 Intervention
Group IV: 160 mg groupExperimental Treatment1 Intervention
Group V: 120 mg groupExperimental Treatment1 Intervention
Group VI: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corxel Pharmaceuticals

Lead Sponsor

Trials
9
Recruited
1,500+