DRUG
Ecnoglutide high dosage
Administered subcutaneously
Status
Completed
Phase
Phase 3
Enrollment
623
Locations
1
Results
Not posted
Publications
1
Study 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)
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.
Interventions
DRUG
Administered subcutaneously
DRUG
Administered subcutaneously
DRUG
Administered subcutaneously
DRUG
Administered orally
Timeline
First posted
Jan 11, 2023
Study start
Jan 10, 2023
Primary completion
Jul 3, 2024
Study completion
Oct 12, 2024
Results posted
Not reported
Registry updated
May 8, 2025
Outcomes
Change from baseline in HbA1c
Time frame · Baseline, week 32
Change from baseline in HbA1c
Time frame · Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
Change from baseline in fasting plasma glucose (FPG)
Time frame · Baseline, Week 32 and Week 52
Change from baseline in lipid panel
Time frame · Baseline, Week 32 and Week 52
Change from baseline in body weight
Time frame · Baseline, Week 32 and Week 52
Pharmacokinetics: plasma trough level of XW003
Time frame · Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
ZHONGSHAN Hospital
Shanghai, Shanghai Municipality, China
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