Evaluating the safety and tolerability of an oral medication for obesity and diabetes

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

This study is testing a new oral medication for obesity and diabetes to see if it's safe and how well it works in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. (Industry-sponsored)
• Locations: 1 site (Herston, Queensland)
• Trial ID: NCT05184322 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of an oral ecnoglutide tablet in healthy adults. It is a single-center, double-blind, randomized, multiple-dose, placebo-controlled study involving six cohorts. Participants will undergo a screening period before being randomized to receive either the medication or a placebo. A Safety Review Committee will monitor the trial's progress to ensure participant safety and ethical compliance.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a stable body weight and specific BMI criteria.

Not a fit: Patients with significant medical histories or conditions that could affect study completion may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could lead to a new oral treatment option for managing obesity and type 2 diabetes.

How similar studies have performed: Other studies have shown promise with GLP-1 analogues, but this specific oral formulation is novel.

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;

Where this trial is running

Herston, Queensland

• Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane) — Herston, Queensland, Australia (Recruiting)

Study contacts

• Principal investigator: Richard Friend — Nucleus Network Brisbane Clinic
• Study coordinator: Zhiyi (Alice) Zhu

Conditions Obesity; Type 2 Diabetes Mellitus