XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)

NCT05579314 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: XW014-001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 3

Brief 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. 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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

  11 weeks

• Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities

  11 weeks

Study Arms (8)

SAD Cohort A - XW014

ACTIVE COMPARATOR

Single oral XW014 administration

Drug: XW014

SAD Cohort A - Placebo

PLACEBO COMPARATOR

Single oral placebo administration

Drug: Placebo

MAD Cohort B - XW014

ACTIVE COMPARATOR

MAD in Healthy Subjects with Elevated BMI

Drug: XW014

MAD Cohort B - Placebo

PLACEBO COMPARATOR

MAD in Healthy Subjects with Elevated BMI

Drug: Placebo

MAD Cohort C - XW014

ACTIVE COMPARATOR

MAD in Patients with T2DM

Drug: XW014

MAD Cohort C - Placebo

PLACEBO COMPARATOR

MAD in Patients with T2DM

Drug: Placebo

MAD Cohort B-EXT - XW014

ACTIVE COMPARATOR

MAD in Healthy Subjects with Elevated BMI

Drug: XW014

MAD Cohort B-EXT - Placebo

ACTIVE COMPARATOR

MAD in Healthy Subjects with Elevated BMI

Drug: Placebo

Interventions

XW014 DRUG

Oral tablets

MAD Cohort B-EXT - XW014; MAD Cohort C - XW014

Placebo DRUG

Matched oral placebo tablets

MAD Cohort B-EXT - Placebo; MAD Cohort C - Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciwind Biosciences USA Co., Ltd.: lead

Study Sites (3)

ICON - Early Development Services

Lenexa, Kansas, 66219, United States

Location

ICON - Early Development Services

San Antonio, Texas, 78209, United States

Location

ICON - Early Development Services

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susan Xu, MD

  Sciwind Biosciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 13, 2022
• Study Start: September 26, 2022
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: September 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)