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

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

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)

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; T2DM
• Intervention / Treatment: Drug: Metformin; Drug: Dulaglutide; Drug: Ecnoglutide high dosage; Drug: Ecnoglutide low dosage

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.

• Study Type: Interventional
• Enrollment (Actual): 623
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan 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 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.
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 insulin during the 6 months preceding screening
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to 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: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B1: XW003+MET; High dosage of XW003 once weekly	Drug: Metformin; Administered orally; Drug: Ecnoglutide high dosage; Administered subcutaneously; Other Names: XW003
Experimental: B2: XW003+MET; Low dosage of XW003 once weekly	Drug: Metformin; Administered orally; Drug: Ecnoglutide low dosage; Administered subcutaneously; Other Names: XW003
Active Comparator: B3: Dulaglutide+MET; 1.5mg Dulaglutide once weekly	Drug: Metformin; Administered orally; Drug: Dulaglutide; Administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
Change from baseline in fasting plasma glucose (FPG)	Baseline, Week 32 and Week 52
Change from baseline in lipid panel	Baseline, Week 32 and Week 52
Change from baseline in body weight	Baseline, Week 32 and Week 52
Pharmacokinetics: plasma trough level of XW003	Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Xiaoying Li, Dr, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): October 12, 2024

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 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; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin; Dulaglutide
• Other Study ID Numbers: SCW0502-1032

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