Clinical trial NCT05680155: A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM
Type 2 Diabetes Mellitus
Keywords: T2DM
Glucagon-like peptide-1
Ecnoglutide
XW003
GLP-1
Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-11
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: Baseline, Week 24 and Week 52
measure: Change from baseline in lipid panel
timeFrame: Baseline, Week 24 and Week 52
measure: Change from baseline in body weight
timeFrame: Baseline, Week 24 and Week 52
measure: Pharmacokinetics: plasma trough level of XW003
timeFrame: Baseline, Day 29, Day 57, Day 85, D168, D364, D399
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Dalong Zhu
role: PRINCIPAL_INVESTIGATOR
References: