Phase
Condition
Diabetes Mellitus, Type 2
Obesity
Diabetes Prevention
Treatment
T2026
Oral ecnoglutide tablet
Placebo
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Healthy male or female participants, aged 18 to 55 years (inclusive at the time ofinformed consenting);
Participants must be in good general health, with no significant medical history,and have no clinically significant abnormalities on physical examination atScreening and/or before administration of study drug;
Stable body weight for at least 3 months prior to Screening (i.e., <5% change) byself-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 ≥30.0kg/m2 and <40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);
Exclusion
Key Exclusion Criteria:
Prior or ongoing medical conditions, medical history, physical findings, orlaboratory abnormality that, in the Investigator's (or delegate's) opinion, mayrequire treatment or render the participant unlikely to fully complete the study, orany condition that presents undue risk from the investigational product (IP) orprocedures or interfere with study assessments;
Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms atany 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 endocrineneoplasia type 2;
Study Design
Study Description
Connect with a study center
Q-Pharm Pty Ltd
Brisbane, Queensland 4006
AustraliaSite Not Available
Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
Herston, Queensland 4006
AustraliaActive - Recruiting
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