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New weight loss drug IBIO-600 enters first human trial

NCT ID NCT07487376

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a single dose of the experimental drug IBIO-600 in 32 overweight or obese adults. The main goal is to see if the drug is safe and tolerable, and to measure how it moves through the body. Researchers will also look at its effect on body composition. This is a first step toward possibly developing a new weight management treatment.

What this could mean

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

Active substance
IBIO-600
What this could lead to
If it works, this could point toward a new treatment for weight management in people who are overweight or obese.
What could go wrong
This is a very early Phase 1 trial with only 32 participants, so it's primarily checking safety, not effectiveness. The drug may not lead to meaningful weight loss or could have side effects.
Why investors are watching

iBio is a very small publicly traded company, and this phase 1 trial is its first test of IBIO-600 in people. The study gives 32 overweight or obese adults a single dose to check safety and whether the drug changes body composition. For a micro-cap company, this early readout is a key signal about whether its lead drug has a future.

If it works: If IBIO-600 proves safe and shows a hint of effect on body composition, iBio could advance the drug to larger studies. That progress could raise the company's profile and support its value as a drug developer.

If it fails: Phase 1 trials often fail on safety or tolerability, and this one has only 32 participants, so results may be unclear. A poor outcome or a delay could hurt iBio's prospects, since the company has few other public assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

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

About 32 people

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

Started

May 2026

Expected to finish

May 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 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Aged 18 to 65 years of age * In good general health, with no significant medical history * BMI between ≥ 27.0 and ≤ 34.90 kg/m2 * History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening. * Willingness to refrain from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study * Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity. * Be a nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization. * Must not be pregnant or breastfeeding * Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer. Exclusion Criteria: * An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol. * History or active diagnosis of diabetes (Type 1 or 2). * History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months). * History or presence of clinically significant muscle disease * History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension. * Clinically significant laboratory abnormalities that would preclude participation in the study. * History of malignancy, except for non-melanoma skin cancer excised \> 2 years ago or cervical intraepithelial neoplasia successfully treated \> 5 years prior to randomization. * History or presence of any condition associated with significant immunosuppression. * History of substance abuse or dependency, or recreational IV drug use within the past 5 years (self-reported).

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

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

    1 site. 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

  • Veritus Research

    RECRUITING

    Bayswater, Victoria, 3153, Australia

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