NCT05579314CompletedPhase 1
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 127 (actual)
- First submitted
- 27 Sept 2022
- Start date
- 26 Sept 2022
- Primary completion date
- 16 Nov 2024
- Lead sponsor
- Sciwind Biosciences USA Co., Ltd.
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05579314
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 127
- From 26 Sept 2022 to the primary completion date, 16 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
Other
- History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICON - Early Development Services Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| ICON - Early Development Services Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| ICON - Early Development Services Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.