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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; T2DM
• Intervention / Treatment: Drug: Ecnoglutide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
2. Sex: male or female; Age: 18 to 75 years, inclusive
3. BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
4. Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive
6. FPG ≤13.9 mmol/L at screening.

Exclusion Criteria:

1. History of type 1 or other types of diabetes mellitus.
2. Use of any GLP-1 analogue during the 3 months preceding to screening.
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
4. History of acute or chronic pancreatitis or high risk factors for pancreatitis.
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
7. History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C1-XW003; High dosage of XW003 once weekly	Drug: Ecnoglutide; Subcutaneous Injection; Other Names: XW003
Placebo Comparator: C1-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Experimental: C2-XW003; Low dosage of XW003 once weekly	Drug: Ecnoglutide; Subcutaneous Injection; Other Names: XW003
Placebo Comparator: C2-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Change from baseline in fasting plasma glucose (FPG)	Baseline, Week 24 and Week 52
Change from baseline in lipid panel	Baseline, Week 24 and Week 52
Change from baseline in body weight	Baseline, Week 24 and Week 52
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment	week 24, week 52
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain	week 24
Change from baseline in fasting insulin	Baseline, Week 24 and Week 52
Change from baseline in 2-hour postprandial blood glucose	Baseline, Week 24 and Week 52
Change from baseline in 7-point self-monitored blood glucose	Baseline, Week 24 and Week 52
Change from baseline in HOMA-IR	Baseline, Week 24 and Week 52
Change from baseline in HOMA-β	Baseline, Week 24 and Week 52
Change from baseline in waist circumference	Baseline, Week 24 and Week 52
Change from baseline in hip circumference	Baseline, Week 24 and Week 52

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	from baseline to EOS
Pharmacokinetics: plasma trough level of XW003	Baseline, D29, D57, D85, D168, D197, D225, D253, D364, D399
Immunogenecity of XW003	Baseline, D85, D168, D253, D399

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): October 12, 2024

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: GLP-1; T2DM; Glucagon-like peptide-1; Ecnoglutide; XW003
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: SCW0502-1031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No