Type 2 Diabetes MellitusPhase 1NCT05579314
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing XW014 in people with Type 2 Diabetes Mellitus, run by Sciwind Biosciences USA Co., Ltd. at 3 sites in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- XW014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Sep 2022to 16 Nov 2024
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
- Sex: male or female
- Weight: >50 kg, inclusive, at screening
- Age:
- For Part A 18 to 70 years, inclusive, at screening
- For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
Show all 11Show fewer
- Body Mass Index
- For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
- For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
- For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
- Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Who cannot join
- History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
- Uncontrolled hypertension
- History of type 1 diabetes mellitus
- History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ICON - Early Development Services
Lenexa, Kansas, 66219
ICON - Early Development Services
Salt Lake City, Utah, 84124
ICON - Early Development Services
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. This study will consist of 4 parts: a Single Ascending Dose (SAD) part in healthy subjects (Part A), and Multiple Ascending Dose (MAD) parts in healthy subjects with elevated BMI (Part B and Part B-EXT) and patients with T2DM [Optional] (Part C).
Read the detailed description
Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.
Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- XW014, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XW014Drug
Oral tablets
PlaceboDrug
Matched oral placebo tablets
XW014Drug
Oral capsules
PlaceboDrug
Matched oral placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort A - XW014 | Active comparator | Single oral XW014 administration Receives: Drug: XW014 |
| SAD Cohort A - Placebo | Placebo comparator | Single oral placebo administration Receives: Drug: Placebo |
| MAD Cohort B - XW014 | Active comparator | MAD in Healthy Subjects with Elevated BMI Receives: Drug: XW014 |
| MAD Cohort B - Placebo | Placebo comparator | MAD in Healthy Subjects with Elevated BMI Receives: Drug: Placebo |
| MAD Cohort C - XW014 | Active comparator | MAD in Patients with T2DM Receives: Drug: XW014 |
| MAD Cohort C - Placebo | Placebo comparator | MAD in Patients with T2DM Receives: Drug: Placebo |
| MAD Cohort B-EXT - XW014 | Active comparator | MAD in Healthy Subjects with Elevated BMI Receives: Drug: XW014 |
| MAD Cohort B-EXT - Placebo | Active comparator | MAD in Healthy Subjects with Elevated BMI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Measured: 11 weeks
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start26 Sep 2022
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciwind Biosciences USA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Xu, MD, Study chair, Sciwind Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579314
- Sponsor's protocol ID
- XW014-001
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05579314
- Acronym / sponsor ID
- XW014-001
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Sciwind Biosciences USA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 13 Oct 2022 (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 Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. This study will consist of 4 parts: a Single Ascending Dose (SAD) part in healthy subjects (Part A), and Multiple Ascending Dose (MAD) parts in healthy subjects with elevated BMI (Part B and Part B-EXT) and patients with T2DM [Optional] (Part C).
Detailed description
Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.
Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort A - XW014 | Active comparator | Drug: XW014Single oral XW014 administration |
| SAD Cohort A - Placebo | Placebo comparator | Drug: PlaceboSingle oral placebo administration |
| MAD Cohort B - XW014 | Active comparator | Drug: XW014MAD in Healthy Subjects with Elevated BMI |
| MAD Cohort B - Placebo | Placebo comparator | Drug: PlaceboMAD in Healthy Subjects with Elevated BMI |
| MAD Cohort C - XW014 | Active comparator | Drug: XW014MAD in Patients with T2DM |
| MAD Cohort C - Placebo | Placebo comparator | Drug: PlaceboMAD in Patients with T2DM |
| MAD Cohort B-EXT - XW014 | Active comparator | Drug: XW014MAD in Healthy Subjects with Elevated BMI |
| MAD Cohort B-EXT - Placebo | Active comparator | Drug: PlaceboMAD in Healthy Subjects with Elevated BMI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
- Sex: male or female
- Weight: >50 kg, inclusive, at screening
- Age:
- Body Mass Index
Key exclusion criteria (6 listed)
- History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
- Uncontrolled hypertension
- History of type 1 diabetes mellitus
- History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
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 |
|---|---|---|
| XW014Oral tablets | Drug | MAD Cohort B-EXT - XW014, MAD Cohort C - XW014 |
| PlaceboMatched oral placebo tablets | Drug | MAD Cohort B-EXT - Placebo, MAD Cohort C - Placebo |
| XW014Oral capsules | Drug | MAD Cohort B - XW014, SAD Cohort A - XW014 |
| PlaceboMatched oral placebo capsules | Drug | MAD Cohort B - Placebo, SAD Cohort A - Placebo |
Primary outcome
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame: 11 weeks
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Time frame: 11 weeks
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Susan Xu, MD study chair
Sciwind Biosciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XW014 in people with Type 2 Diabetes Mellitus, run by Sciwind Biosciences USA Co., Ltd. at 3 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 11 inclusion and 6 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) (time frame: 11 weeks). The study lists 2 primary outcomes in all. 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 19 Sep 2025.