XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

Sciwind Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05184322

SCW0503-1011

Details and patient eligibility

About

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

Full description

This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
• Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
• Stable body weight for at least 3 months prior to Screening (i.e., <5% change) by self-declaration;
• Participants must have a Body Mass Index (BMI) ≥22.0 kg/m2 and <32.0 kg/m2 and weigh ≥55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI ≥30.0 kg/m2 and <40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Key Exclusion Criteria:

• Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
• Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 6 patient groups

Cohort 1A/1B

Experimental group

Description:

Cohort 1A/1B will enroll 14 healthy participants.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Cohort 2

Experimental group

Description:

Cohort 2 will enroll 14 healthy participants.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Cohort 3

Experimental group

Description:

Cohort 3 will enroll 14 healthy participants.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Cohort 4

Experimental group

Description:

Cohort 4 will enroll 14 otherwise healthy participants with obesity.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Cohort 5

Experimental group

Description:

Cohort 5 will enroll 14 otherwise healthy participants with obesity.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Placebo

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Cohort 6

Experimental group

Description:

Cohort 6 will enroll 14 otherwise healthy participants with obesity.

Treatment:

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: Oral ecnoglutide tablet

Drug: T2026