Clinical trial NCT05680129: A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
Official title: A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM
Type 2 Diabetes Mellitus
Keywords: T2DM
Glucagon-like peptide-1
GLP-1
Ecnoglutide
XW003
Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-11
Enrollment: 623
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 aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Detailed description: In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

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 T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks 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 insulin during the 6 months preceding screening
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to 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 32
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: Baseline, Week 32 and Week 52
measure: Change from baseline in lipid panel
timeFrame: Baseline, Week 32 and Week 52
measure: Change from baseline in body weight
timeFrame: Baseline, Week 32 and Week 52
measure: Pharmacokinetics: plasma trough level of XW003
timeFrame: Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ZHONGSHAN Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xiaoying Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: