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

Obesity Clinical Trial

Official title:

A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05184322
• Other study ID #: SCW0503-1011
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2022
• Source: Sciwind Biosciences APAC CO Pty. Ltd.
• Contact: HONG QIN
• Phone: (+86)13679290113
• Email: hong.qin[@]sciwindbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a single-centre, double-blind, randomised, multiple ascending dose, placebo-controlled study including four cohorts. All cohorts will have treatment regimens consisting of 15-day once daily dosing and a follow-up visit 21 days after last dosing. Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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;

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• XW004
2, 7, 15, 30mg tablets once daily for 15 days.
• T2026
Once daily for 15 days.
• Placebo
Once daily for 15 days.

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Sciwind Biosciences APAC CO Pty. Ltd.	Hangzhou Sciwind Biosciences Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Count of adverse events	36 days
Secondary	Maximum observed drug concentration	Calculated based on XW003 measured in blood.	36 days
Secondary	Time of the maximum drug concentration	Calculated based on XW003 measured in blood	36 days
Secondary	Maximum plasma concentration after last dosing	Calculated based on XW003 measured in blood	36 days
Secondary	Change from Baseline in body weight	Percentage of body weight loss	36 days
Secondary	Change from Baseline in fasting plasma glucose	Percentage of fasting plasma glucose change	36 days
Secondary	Maximum observed drug concentration T2026	Calculated based on T2026 measured in blood.	36 days
Secondary	Time of the maximum drug concentration T2026	Calculated based on T2026 measured in blood.	36 days
Secondary	Maximum plasma concentration after last dosing T2026	Calculated based on T2026 measured in blood.	36 days
Secondary	Incidence of anti-XW004 antibodies at end of study	Count of episodes	36 days