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New diabetes pill enters first human safety tests

NCT ID NCT05579314

Disease control Sponsor: Sciwind Biosciences USA Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tests an experimental oral drug called XW014 in healthy volunteers and people with type 2 diabetes. The main goal is to check safety and how the body handles the drug. 127 participants will receive either the drug or a placebo in single or multiple doses. This is a first-in-human study, so it's too early to know if the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XW014 (oral tablet or capsule)
What this could lead to
If successful, this could lead to a new oral medication for type 2 diabetes that helps control blood sugar.
What could go wrong
This is a very early Phase 1 trial focused on safety, not effectiveness. The drug may not work or could have side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

127 people

The number who actually took part.

Started

Sep 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures 2. Sex: male or female 3. Weight: \>50 kg, inclusive, at screening 4. Age: 1. For Part A 18 to 70 years, inclusive, at screening 2. For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening 5. Body Mass Index 1. For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening 2. For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening 3. For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening 6. Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C) Key Exclusion Criteria: 1. History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system 2. Uncontrolled hypertension 3. History of type 1 diabetes mellitus 4. History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis 5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma 6. Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • ICON - Early Development Services

    Lenexa, Kansas, 66219, United States

  • ICON - Early Development Services

    San Antonio, Texas, 78209, United States

  • ICON - Early Development Services

    Salt Lake City, Utah, 84124, United States

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