A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Sciwind Biosciences

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus; T2DM

Treatments: Drug: Metformin; Drug: Ecnoglutide high dosage; Drug: Ecnoglutide low dosage; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05680129

SCW0502-1032

Details and patient eligibility

About

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)

Full 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.

Enrollment: 623 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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623 participants in 3 patient groups

B1: XW003+MET

Experimental group

Description:

High dosage of XW003 once weekly

Treatment:

Drug: Ecnoglutide high dosage

Drug: Metformin

B2: XW003+MET

Experimental group

Description:

Low dosage of XW003 once weekly

Treatment:

Drug: Ecnoglutide low dosage

Drug: Metformin

B3: Dulaglutide+MET

Active Comparator group

Description:

1.5mg Dulaglutide once weekly

Treatment:

Drug: Dulaglutide

Drug: Metformin