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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; T2DM
• Interventions: Drug: Ecnoglutide low dosage; Drug: Ecnoglutide high dosage; Drug: Dulaglutide; Drug: Metformin

• Registration Number: NCT05680129
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2022-12-25
• Study Start: 2023-01-10
• Study First Posted: 2023-01-11
• Status Verified: 2023-07
• Primary Completion: 2024-07-03
• Study Completion: 2024-10-12
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B2: XW003+MET	Ecnoglutide low dosage	Low dosage of XW003 once weekly
B1: XW003+MET	Ecnoglutide high dosage	High dosage of XW003 once weekly
B1: XW003+MET	Metformin	High dosage of XW003 once weekly
B2: XW003+MET	Metformin	Low dosage of XW003 once weekly
B3: Dulaglutide+MET	Metformin	1.5mg Dulaglutide once weekly
B3: Dulaglutide+MET	Dulaglutide	1.5mg Dulaglutide once weekly

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, week 32

Secondary Outcome Measures

Name	Time	Method
Change from baseline in lipid panel	Baseline, Week 32 and Week 52
Change from baseline in fasting plasma glucose (FPG)	Baseline, Week 32 and Week 52
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 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

Trial Locations

Locations (1)

ZHONGSHAN Hospital; 🇨🇳 Shanghai, Shanghai, China