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

Sciwind Biosciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 2 Diabetes Mellitus; T2DM

Treatments: Drug: Ecnoglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05680155

SCW0502-1031

Details and patient eligibility

About

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

Full 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.

Enrollment: 211 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 4 patient groups, including a placebo group

C1-XW003

Experimental group

Description:

High dosage of XW003 once weekly

Treatment:

Drug: Ecnoglutide

C1-Placebo

Placebo Comparator group

Description:

Matched Placebo once weekly

Treatment:

Drug: Placebo

C2-XW003

Experimental group

Description:

Low dosage of XW003 once weekly

Treatment:

Drug: Ecnoglutide

C2-Placebo

Placebo Comparator group

Description:

Matched Placebo once weekly

Treatment:

Drug: Placebo