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XW014 for Type 2 Diabetes

Phase 1
Recruiting
Research Sponsored by Sciwind Biosciences USA Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Weight: >50 kg at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights

Study Summary

This trial will test a new drug's safety, tolerability, food effect, and pharmacological effects in healthy people and patients with type 2 diabetes.

Who is the study for?
This trial is for healthy individuals and those with Type 2 Diabetes Mellitus (T2DM). Participants must be willing to consent, weigh over 50 kg, and be aged 18-70 years for Part A or 18-55 years for Parts B and C. T2DM patients should have had the condition for at least six months with an HbA1c level between 6.5% to 8.5%. People with uncontrolled hypertension, type 1 diabetes, significant active diseases, or a history of certain thyroid cancers are excluded.Check my eligibility
What is being tested?
The study tests XW014's safety and effects in humans when taken orally. It has three parts: one where healthy subjects take a single dose (SAD), another where overweight healthy subjects take multiple doses (MAD), and the last part involves T2DM patients taking multiple doses to see how their bodies react over time.See study design
What are the potential side effects?
Possible side effects aren't specified but generally may include issues related to digestion, blood sugar levels fluctuating due to the medication's effect on diabetes control, allergic reactions if sensitive to components in XW014 or placebo ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had type 2 diabetes for over 6 months with an HbA1c between 6.5% and 8.5%.
Select...
I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electrocardiogram
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: MAD Cohort B - XW014Active Control1 Intervention
MAD in Healthy Subjects with Elevated BMI
Group II: SAD Cohort A - XW014Active Control1 Intervention
Single oral XW014 administration
Group III: MAD Cohort C - XW014Active Control1 Intervention
MAD in Patients with T2DM
Group IV: MAD Cohort C - PlaceboPlacebo Group1 Intervention
MAD in Patients with T2DM
Group V: MAD Cohort B - PlaceboPlacebo Group1 Intervention
MAD in Healthy Subjects with Elevated BMI
Group VI: SAD Cohort A - PlaceboPlacebo Group1 Intervention
Single oral placebo administration

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sciwind Biosciences USA Co., Ltd.Lead Sponsor
1 Previous Clinical Trials

Media Library

XW014 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05579314 — Phase 1
Type 2 Diabetes Research Study Groups: MAD Cohort C - Placebo, MAD Cohort B - Placebo, SAD Cohort A - Placebo, MAD Cohort B - XW014, SAD Cohort A - XW014, MAD Cohort C - XW014
Type 2 Diabetes Clinical Trial 2023: XW014 Highlights & Side Effects. Trial Name: NCT05579314 — Phase 1
XW014 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579314 — Phase 1
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05579314 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial contingent upon the participant being of legal age?

"The boundaries for eligibility in this trial are set between 18 and 70 years of age, as outlined by the inclusion criteria."

Answered by AI

Am I eligible to partake in this clinical research?

"Participants in this clinical trial should have a diagnosis of type 2 diabetes mellitus, and must be within the ages 18-70. The total enrolment is set at 104 individuals."

Answered by AI

Are there still vacancies available in this clinical trial?

"Affirmative. Clinicaltrials.gov records show that this research study, which was originally made public on September 26th 2022, is accepting participants at the moment. 104 individuals must be registered from 3 different medical centres."

Answered by AI

How many test subjects are being monitored for this research experiment?

"Affirmative. The clinicaltrials.gov website testifies that this research endeavour is presently recruiting individuals, with initial posting on September 26th 2022 and recent alteration occurring on October 11st of the same year. 104 persons spanning 3 healthcare centres must be enrolled for successful completion."

Answered by AI

Has the SAD Cohort A - XW014 obtained regulatory clearance from the FDA?

"Our Power team gave SAD Cohort A - XW014 a score of 1, due to the fact that this is an exploratory Phase 1 trial with limited safety and efficacy data."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
ICON - Early Development Services
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

I am hoping that this trial will help my medical conditions in the future.
PatientReceived no prior treatments
I've teied several medications to treat my Type 2 Diabetes. Looking for something that will work.
PatientReceived 1 prior treatment
I've tried other drugs and either they aren't effective, or the side effects are horrible, or they are so popular for weight loss that it is difficult to find them available for use with diabetes. When I saw this study, I was excited that a new drug might soon be available.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screenings take? How many times would I need to drive to San Antonio? Will I need to stop taking any of my current medications?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. ICON - Early Development Services: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
2022. "XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579314.
~42 spots leftby Apr 2025
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