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

Phase 3

Completed

• Conditions: T2DM; Type 2 Diabetes Mellitus
• Interventions: Drug: Ecnoglutide; Drug: Placebo

• Registration Number: NCT05680155
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-12-25
• Study Start: 2022-12-29
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-11
• Status Verified: 2023-07
• Primary Completion: 2024-06-12
• 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: 211

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C1-XW003	Ecnoglutide	High dosage of XW003 once weekly
C2-Placebo	Placebo	Matched Placebo once weekly
C1-Placebo	Placebo	Matched Placebo once weekly
C2-XW003	Ecnoglutide	Low dosage of XW003 once weekly

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in lipid panel	Baseline, Week 24 and Week 52
Change from baseline in body weight	Baseline, Week 24 and Week 52
Pharmacokinetics: plasma trough level of XW003	Baseline, Day 29, Day 57, Day 85, D168, D364, D399
Change from baseline in fasting plasma glucose (FPG)	Baseline, Week 24 and Week 52
Change from baseline in HbA1c	Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China