NCT05184322CompletedPhase 1
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 21 Dec 2021
- Start date
- 12 Apr 2022
- Primary completion date
- 13 Jul 2024
- Lead sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05184322
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 87
- From 12 Apr 2022 to the primary completion date, 13 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
Lab values
- 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;
Who the study is looking for
- 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);
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane) Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.