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

• ClinicalTrials.gov Identifier: NCT05680155
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2023
• Last Update Posted: July 17, 2023
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Information provided by (Responsible Party): Hangzhou Sciwind Biosciences Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
T2DM; Type 2 Diabetes Mellitus	Drug: Ecnoglutide; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 29, 2022
• Estimated Primary Completion Date: October 21, 2024
• Estimated Study Completion Date: October 21, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: C1-XW003; High dosage of XW003 once weekly	Drug: Ecnoglutide; Subcutaneous Injection; Other Name: XW003
Placebo Comparator: C1-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Experimental: C2-XW003; Low dosage of XW003 once weekly	Drug: Ecnoglutide; Subcutaneous Injection; Other Name: XW003
Placebo Comparator: C2-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in HbA1c [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Jiangsu

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China, 210008

Sponsors and Collaborators

Hangzhou Sciwind Biosciences Co., Ltd.

Investigators

• Principal Investigator: Dalong Zhu; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

More Information

• Responsible Party: Hangzhou Sciwind Biosciences Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05680155
• Other Study ID Numbers: SCW0502-1031
• First Posted: January 11, 2023
• Last Update Posted: July 17, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hangzhou Sciwind Biosciences Co., Ltd.:

T2DM; Glucagon-like peptide-1; Ecnoglutide; XW003; GLP-1

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases