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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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T2DM, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Ecnoglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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/m^2 to 35.0 kg/m^2, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C1-XW003<br>High dosage of XW003 once weekly | Drug: Ecnoglutide<br>* Subcutaneous Injection<br>* Other names: XW003;|
| Placebo Comparator: C1-Placebo<br>Matched Placebo once weekly | Drug: Placebo<br>* Subcutaneous Injection with matched volume<br>|
| Experimental: C2-XW003<br>Low dosage of XW003 once weekly | Drug: Ecnoglutide<br>* Subcutaneous Injection<br>* Other names: XW003;|
| Placebo Comparator: C2-Placebo<br>Matched Placebo once weekly | Drug: Placebo<br>* Subcutaneous Injection with matched volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, Glucagon-like peptide-1, Ecnoglutide, XW003, GLP-1