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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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);

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;

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-12

Primary completion: 2024-07-01

Study completion finish: 2024-08-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05184322

Intervention or treatment

DRUG: T2026

DRUG: Placebo

DRUG: Oral ecnoglutide tablet

DRUG: T2026

DRUG: Placebo

DRUG: T2026

DRUG: Placebo

Conditions

• Obesity
• Type 2 Diabetes Mellitus

Condition: Obesity, Type 2 Diabetes Mellitus
DRUG: T2026 and other drugs
Herston, Queensland, Australia
Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)

Research sites nearby

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1A/1B Cohort 1A/1B will enroll 14 healthy participants.	DRUG: T2026 Once daily for 15 days.
EXPERIMENTAL: Cohort 2 Cohort 2 will enroll 14 healthy participants.	DRUG: T2026 Once daily for 15 days.
EXPERIMENTAL: Cohort 3 Cohort 3 will enroll 14 healthy participants.	DRUG: T2026 Once daily for 15 days.
EXPERIMENTAL: Cohort 4 Cohort 4 will enroll 14 otherwise healthy participants with obesity.	DRUG: Oral ecnoglutide tablet Once daily for 6 weeks.
EXPERIMENTAL: Cohort 5 Cohort 5 will enroll 14 otherwise healthy participants with obesity.	DRUG: Oral ecnoglutide tablet Once daily and titrated up in concentration to once every week during maintenance period.
EXPERIMENTAL: Cohort 6 Cohort 6 will enroll 14 otherwise healthy participants with obesity.	DRUG: T2026 Once daily for 15 days.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)	Count of adverse events	Up to 98 days

Secondary outcome

Frequently Asked Questions

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References

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

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

Study details:

Eligibility criteria

Inclusion criteria

Exclusion criteria

Eligibility

Things to know

Study dates

Study type

Phase

Trial ID

Intervention or treatment

Conditions

Find a site

Research sites nearby

Study Plan

How is the study designed?

What is the study measuring?

Primary outcome

Secondary outcome

Frequently Asked Questions

References

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