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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05680129
• Other study ID #: SCW0502-1032
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: October 3, 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 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 623
• Est. completion date: October 3, 2024
• Est. primary completion date: October 3, 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 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ecnoglutide high dosage
Administered subcutaneously
• Ecnoglutide low dosage
Administered subcutaneously
• Dulaglutide
Administered subcutaneously
• Metformin
Administered orally

Locations

Country	Name	City	State
China	ZHONGSHAN Hospital	Shanghai	Shanghai

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