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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05680155
• Other study ID #: SCW0502-1031
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 29, 2022
• Est. completion date: October 21, 2024

Study information

• Verified date: July 2023
• Source: Hangzhou Sciwind Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: October 21, 2024
• Est. primary completion date: October 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• T2DM
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ecnoglutide
Subcutaneous Injection
• Placebo
Subcutaneous Injection with matched volume

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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