A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
Study Details
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 |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: C1-XW003 High dosage of XW003 once weekly |
Drug: Ecnoglutide
Subcutaneous Injection
Other Names:
|
| 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 Names:
|
| Placebo Comparator: C2-Placebo Matched Placebo once weekly |
Drug: Placebo
Subcutaneous Injection with matched volume
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in HbA1c [Baseline, Week 24]
Secondary Outcome Measures
- Change from baseline in HbA1c [Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52]
- Change from baseline in fasting plasma glucose (FPG) [Baseline, Week 24 and Week 52]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
-
Sex: male or female; Age: 18 to 75 years, inclusive
-
BMI: 20.0 kg/m2 to 35.0 kg/m2, inclusive
-
Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
-
HbA1c ranging from 7.5% to 11.0% at screening, inclusive
-
FPG ≤13.9 mmol/L at screening.
Exclusion Criteria:
-
History of type 1 or other types of diabetes mellitus.
-
Use of any GLP-1 analogue during the 3 months preceding to screening.
-
History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
-
History of acute or chronic pancreatitis or high risk factors for pancreatitis.
-
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
-
History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
-
History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
Sponsors and Collaborators
- Hangzhou Sciwind Biosciences Co., Ltd.
Investigators
- Principal Investigator: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCW0502-1031