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

Launched by SCIWIND BIOSCIENCES APAC CO PTY. LTD. · Jan 6, 2022

Keywords

ClinConnect Summary

This clinical trial, called XW004, is looking at a new oral medication called Ecnoglutide, which is designed to help with obesity and type 2 diabetes. The main goal is to see how safe the medication is, how well it is tolerated by people, and how the body processes it. The study is currently recruiting healthy adults aged 18 to 55 who meet specific health criteria, such as having a stable body weight and a body mass index (BMI) within certain ranges.

Participants in the trial will undergo health screenings to ensure they are in good general health and do not have any significant medical conditions that could interfere with the study. If you qualify, you can expect to take the medication and attend follow-up appointments to monitor your health and any effects of the treatment. It's important to note that individuals with a history of diabetes or certain thyroid conditions cannot participate. This study aims to gather valuable information that could lead to new treatment options for managing obesity and type 2 diabetes.

Gender

ALL

Eligibility 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;