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New drug IGT-303 tested for safety in kidney disease patients

NCT ID NCT07231679

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the safety of a new drug called IGT-303 in healthy volunteers and people with chronic kidney disease (CKD). About 94 participants will receive either the drug or a placebo, given as a shot under the skin or into a vein. Researchers will monitor for side effects to see if IGT-303 is safe enough for further testing.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

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 75 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: * Participant 18-75 years of age, inclusive, at Screening; * Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent; * Body mass index (BMI) within the range of 18.5 to 40 kg/m2 at Screening; * Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy; * UACR \>30 mg/g, \<5000 mg/g at Screening and Day -1; * If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening; * Participants assigned male at birth (AMAB) will be either sterile or agree to use an approved method of contraception from Screening until at least 5 half-lives plus 90 days after the last dose of study drug, or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from sperm donation and in vitro fertilization until 5 half-lives plus 90 days after the last dose of the study drug; Participants assigned female at birth (AFAB) must be of non-childbearing potential or agree to use two highly effective methods of conception from Screening until at least 5 half-lives plus 30 days after the last dose of study drug or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from egg donation and in vitro fertilization until 5 half-lives plus 30 days after the last dose of the study drug * In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site; * For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy Exclusion Criteria: * Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food/drug allergies; * Use of cigarettes exceeding \>5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement; * Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1; * Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data * For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Momentum Clinical Research

    RECRUITING

    Waikanae Beach, Kapiti Coast, 5036, New Zealand

  • Nucleus Network

    RECRUITING

    Herston, Brisbane, 4006, Australia

  • Pacific Clinical Research Network

    RECRUITING

    Takapuna, Auckland, 0622, New Zealand

  • University of Sunshine Coast-Morayfield

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • University of the Sunshine Coast Clinical Trials-Southbank

    RECRUITING

    Morayfield, Queensland, 4506, Australia

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