ObesityPhase 1NCT05184322

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

A Phase 1 study testing T2026 and Oral ecnoglutide tablet in people with Obesity and Type 2 Diabetes Mellitus, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Type 2 Diabetes Mellitus
What is being tested?: T2026 and Oral ecnoglutide tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteAustralia
Study dates: 12 Apr 2022to 25 Mar 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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);

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
Herston, Queensland, 4006

Other trials in Australia

About this study

Official title: 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

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.

Read the detailed description

This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Conditions: Obesity, Type 2 Diabetes Mellitus
Being tested: T2026, Placebo, Oral ecnoglutide tablet
Keywords: Obesity, Type 2 Diabetes Mellitus
Medical subject headings: Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T2026Drug
Also called Absorption enhancer excipient
Once daily for 15 days.
PlaceboDrug
Once daily for 15 days.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily for 6 weeks.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily and titrated up in concentration to once every week during maintenance period.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily for 15 days.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily for 15 days.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily for 15 days.
Oral ecnoglutide tabletDrug
Also called GLP-1 analogue, XW004
Once daily for 15 days.
T2026Drug
Also called Absorption enhancer excipient
Once daily for 6 weeks.
PlaceboDrug
Once daily for 6 weeks.
T2026Drug
Also called Absorption enhancer excipient
Once daily to once weekly for 12 weeks.
PlaceboDrug
Once daily to once weekly for 12 weeks.

Study groups in NCT05184322
Study group	Role	What they receive
Cohort 1A/1B	Experimental	Cohort 1A/1B will enroll 14 healthy participants. Receives: Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet
Cohort 2	Experimental	Cohort 2 will enroll 14 healthy participants. Receives: Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet
Cohort 3	Experimental	Cohort 3 will enroll 14 healthy participants. Receives: Drug: T2026; Drug: Placebo; Drug: Oral ecnoglutide tablet
Cohort 4	Experimental	Cohort 4 will enroll 14 otherwise healthy participants with obesity. Receives: Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo
Cohort 5	Experimental	Cohort 5 will enroll 14 otherwise healthy participants with obesity. Receives: Drug: Oral ecnoglutide tablet; Drug: T2026; Drug: Placebo
Cohort 6	Experimental	Cohort 6 will enroll 14 otherwise healthy participants with obesity. Receives: Drug: T2026; Drug: Oral ecnoglutide tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
Count of adverse events
Measured: Up to 98 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202225 Mar 2025

First posted11 Jan 2022
Study start12 Apr 2022
Primary completion13 Jul 2024
Study completion25 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05184322
Sponsor's protocol ID: SCW0503-1011
Status last verified: Nov 2024
First submitted: 21 Dec 2021
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05184322
Acronym / sponsor ID: SCW0503-1011
Conditions: Obesity, Type 2 Diabetes Mellitus
Keywords: Obesity, Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Sciwind Biosciences APAC CO Pty. Ltd.Industry (pharma, biotech, devices)
Collaborators: Hangzhou Sciwind Biosciences Co., Ltd., Sciwind Biosciences USA Co., Ltd.
Study start: 12 Apr 2022 (actual)
Primary completion: 13 Jul 2024 (actual)
Study completion: 25 Mar 2025 (actual)
First posted: 11 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6
Model description: This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design.

Arm	Type	Receives
Cohort 1A/1B	Experimental	Drug: T2026, Drug: Placebo, Drug: Oral ecnoglutide tabletCohort 1A/1B will enroll 14 healthy participants.
Cohort 2	Experimental	Drug: T2026, Drug: Placebo, Drug: Oral ecnoglutide tabletCohort 2 will enroll 14 healthy participants.
Cohort 3	Experimental	Drug: T2026, Drug: Placebo, Drug: Oral ecnoglutide tabletCohort 3 will enroll 14 healthy participants.
Cohort 4	Experimental	Drug: Oral ecnoglutide tablet, Drug: T2026, Drug: PlaceboCohort 4 will enroll 14 otherwise healthy participants with obesity.
Cohort 5	Experimental	Drug: Oral ecnoglutide tablet, Drug: T2026, Drug: PlaceboCohort 5 will enroll 14 otherwise healthy participants with obesity.
Cohort 6	Experimental	Drug: T2026, Drug: Oral ecnoglutide tabletCohort 6 will enroll 14 otherwise healthy participants with obesity.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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 (3 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T2026Also: Absorption enhancer excipientOnce daily for 15 days.	Drug	Cohort 1A/1B, Cohort 2, Cohort 3, Cohort 6
PlaceboOnce daily for 15 days.	Drug	Cohort 1A/1B, Cohort 2, Cohort 3
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily for 6 weeks.	Drug	Cohort 4
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily and titrated up in concentration to once every week during maintenance period.	Drug	Cohort 5
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily for 15 days.	Drug	Cohort 6
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily for 15 days.	Drug	Cohort 1A/1B
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily for 15 days.	Drug	Cohort 2
Oral ecnoglutide tabletAlso: GLP-1 analogue, XW004Once daily for 15 days.	Drug	Cohort 3
T2026Also: Absorption enhancer excipientOnce daily for 6 weeks.	Drug	Cohort 4
PlaceboOnce daily for 6 weeks.	Drug	Cohort 4
T2026Also: Absorption enhancer excipientOnce daily to once weekly for 12 weeks.	Drug	Cohort 5
PlaceboOnce daily to once weekly for 12 weeks.	Drug	Cohort 5

Primary outcome

Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
Time frame: Up to 98 days
Count of adverse events

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Friend principal investigator

Nucleus Network Brisbane Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T2026 and Oral ecnoglutide tablet in people with Obesity and Type 2 Diabetes Mellitus, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE) (time frame: Up to 98 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.