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A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

Primary Purpose

T2DM, Type 2 Diabetes Mellitus

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ecnoglutide
Placebo
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, Ecnoglutide, XW003, GLP-1

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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 any GLP-1 analogue during the 3 months preceding to screening. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding 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

  • Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

C1-XW003

C1-Placebo

C2-XW003

C2-Placebo

Arm Description

High dosage of XW003 once weekly

Matched Placebo once weekly

Low dosage of XW003 once weekly

Matched Placebo 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
NCT05680155
Brief Title
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
Official Title
A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
October 21, 2024 (Anticipated)
Study Completion Date
October 21, 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 main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
Detailed Description
In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.

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, Ecnoglutide, XW003, GLP-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C1-XW003
Arm Type
Experimental
Arm Description
High dosage of XW003 once weekly
Arm Title
C1-Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo once weekly
Arm Title
C2-XW003
Arm Type
Experimental
Arm Description
Low dosage of XW003 once weekly
Arm Title
C2-Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo once weekly
Intervention Type
Drug
Intervention Name(s)
Ecnoglutide
Other Intervention Name(s)
XW003
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Injection with matched volume
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Title
Change from baseline in fasting plasma glucose (FPG)
Time Frame
Baseline, Week 24 and Week 52
Title
Change from baseline in lipid panel
Time Frame
Baseline, Week 24 and Week 52
Title
Change from baseline in body weight
Time Frame
Baseline, Week 24 and Week 52
Title
Pharmacokinetics: plasma trough level of XW003
Time Frame
Baseline, Day 29, Day 57, Day 85, D168, D364, D399

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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 any GLP-1 analogue during the 3 months preceding to screening. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding 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
Dalong Zhu
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
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 Placebo in T2DM Patients

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