XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Obesity, Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Type 2 Diabetes Mellitus
Eligibility Criteria
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;
Sites / Locations
- Q-Pharm Pty Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Cohort 1
Cohort 2
Cohort 3
Cohort 4
T2026 tablet
Placebo tablet
Cohort 1 will enroll 10 healthy participants, doses ranging from 2mg to 7mg.
Cohort 2 will enroll 10 healthy participants, doses ranging from 2mg to 15mg.
Cohort 3 will enroll 10 healthy participants, doses ranging from 7mg to 30mg.
Cohort 4 will enroll 10 otherwise 'healthy' participants with obesity, doses ranging from 7mg to 30mg.
Tablet containing no ecnoglutide but T2026 2 participants receiving T2026 tablet will be enrolled in each cohort.
placebo containing no ecnoglutide or T2026 2 participants receiving placebo tablet will be enrolled in each cohort.