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New drug SEP-479 enters first human safety tests

NCT ID NCT07433179

Knowledge-focused Sponsor: Septerna, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is testing a new drug, SEP-479, in 150 healthy adults aged 21 to 60. The main goal is to check if the drug is safe and how the body processes it. Participants will take single or multiple doses of the drug or a placebo. This study does not aim to treat any disease.

Why investors are watching

Septerna, a very small publicly traded company, is running a phase 1 trial of its drug SEP-479 in 150 healthy adults. The trial tests the drug's safety, how the body processes it, and the effect of food on it. For a micro-cap company, this early readout is a key test of whether the drug is safe enough to keep developing.

If it works: If the trial shows SEP-479 is safe and well tolerated, Septerna could move the drug into later-stage testing. That progress could strengthen the company's position with investors and partners.

If it fails: Phase 1 trials often fail because a drug proves unsafe or has side effects. If SEP-479 fails or the trial is delayed, Septerna, with its small size, would face a major setback with no later-stage product 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 150 people

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

Started

Mar 2026

Expected to finish

Feb 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

21 to 60 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. Subjects who are able and willing to provide informed consent 2. Aged 21 to 60 years at the time of consent 3. Have a BMI within the range 18.0 to 32.0 kg/m2 4. In general good health Exclusion Criteria: 1. Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. 2. Have clinically significant abnormalities on clinical laboratory results. 3. Participation in other clinical trials recently/currently

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As listed by the trial registrant

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

Healthy volunteers

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

  • Nucleus Network

    RECRUITING

    Melbourne, Australia

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