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A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Primary Purpose

T2DM, Type 2 Diabetes Mellitus

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ecnoglutide high dosage
Ecnoglutide low dosage
Dulaglutide
Metformin
Sponsored by
Hangzhou Sciwind Biosciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T2DM focused on measuring T2DM, Glucagon-like peptide-1, GLP-1, Ecnoglutide, XW003

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures Sex: male or female; Age: 18 to 75 years, inclusive BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening. HbA1c ranging from 7.5% to 11.0% at screening, inclusive FPG ≤13.9 mmol/L at screening Exclusion Criteria: History of type 1 or other types of diabetes mellitus Use of insulin during the 6 months preceding screening History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening. History of acute or chronic pancreatitis or high-risk factors for pancreatitis Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.

Sites / Locations

  • ZHONGSHAN Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

B1: XW003+MET

B2: XW003+MET

B3: Dulaglutide+MET

Arm Description

High dosage of XW003 once weekly

Low dosage of XW003 once weekly

1.5mg Dulaglutide once weekly

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in HbA1c
Change from baseline in fasting plasma glucose (FPG)
Change from baseline in lipid panel
Change from baseline in body weight
Pharmacokinetics: plasma trough level of XW003

Full Information

First Posted
December 25, 2022
Last Updated
July 13, 2023
Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05680129
Brief Title
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
Official Title
A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
October 3, 2024 (Anticipated)
Study Completion Date
October 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
Detailed Description
In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2DM, Type 2 Diabetes Mellitus
Keywords
T2DM, Glucagon-like peptide-1, GLP-1, Ecnoglutide, XW003

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B1: XW003+MET
Arm Type
Experimental
Arm Description
High dosage of XW003 once weekly
Arm Title
B2: XW003+MET
Arm Type
Experimental
Arm Description
Low dosage of XW003 once weekly
Arm Title
B3: Dulaglutide+MET
Arm Type
Active Comparator
Arm Description
1.5mg Dulaglutide once weekly
Intervention Type
Drug
Intervention Name(s)
Ecnoglutide high dosage
Other Intervention Name(s)
XW003
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Ecnoglutide low dosage
Other Intervention Name(s)
XW003
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, week 32
Secondary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
Title
Change from baseline in fasting plasma glucose (FPG)
Time Frame
Baseline, Week 32 and Week 52
Title
Change from baseline in lipid panel
Time Frame
Baseline, Week 32 and Week 52
Title
Change from baseline in body weight
Time Frame
Baseline, Week 32 and Week 52
Title
Pharmacokinetics: plasma trough level of XW003
Time Frame
Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures Sex: male or female; Age: 18 to 75 years, inclusive BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening. HbA1c ranging from 7.5% to 11.0% at screening, inclusive FPG ≤13.9 mmol/L at screening Exclusion Criteria: History of type 1 or other types of diabetes mellitus Use of insulin during the 6 months preceding screening History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening. History of acute or chronic pancreatitis or high-risk factors for pancreatitis Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, Dr
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZHONGSHAN Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

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