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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05680155
Recruitment Status : Active, not recruiting
First Posted : January 11, 2023
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Hangzhou Sciwind Biosciences Co., Ltd.

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.

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05680155


Locations
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China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
Hangzhou Sciwind Biosciences Co., Ltd.
Investigators
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Principal Investigator: Dalong Zhu The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Responsible Party: Hangzhou Sciwind Biosciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT05680155    
Other Study ID Numbers: SCW0502-1031
First Posted: January 11, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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