XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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).
Key facts
- Study ID
- NCT05579314
- Run by
- Sciwind Biosciences USA Co., Ltd.
- People needed
- 127
- Starts
- 2022-09-26
- Expected to finish
- 2024-11-16
- Last updated by the study team
- 2025-09-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
- Key Exclusion Criteria:
- 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
Where it is running
- ICON - Early Development Services — Lenexa, Kansas, United States
- ICON - Early Development Services — San Antonio, Texas, United States
- ICON - Early Development Services — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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