Once-a-Month obesity shot put to the test

NCT ID NCT07842640

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing an experimental injection called ASC35 in adults with obesity or overweight. The trial gives single and increasing doses to see how safe the drug is, how well people tolerate it, and how the body processes it. Some participants receive ASC35, some receive a placebo, and others receive tirzepatide, a weekly weight-loss drug, for comparison. The study also tracks changes in body weight.

What this could mean

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

Active substance
ASC35, an experimental once-monthly injection for weight management
What this could lead to
If it works, this could point toward a weight-management injection people take once a month instead of once a week.
What could go wrong
This is a small, early-stage safety trial, so it cannot show whether ASC35 helps people lose weight. Many drugs at this stage fail or cause side effects that stop 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

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

Participants

About 84 people

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

Started

Aug 2026

Expected to finish

Jun 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

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: * Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site. * Are between 18 and 65 years of age (both inclusive) at time of screening. * No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures. Exclusion Criteria: * Have evidence of any clinically significant active or chronic disease. * Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have a history of acute or chronic pancreatitis. * Have a known clinically significant gastric emptying abnormality. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. * Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ascletis Clinical Site

    RECRUITING

    Baltimore, Maryland, 21201, United States

    Contact Email: •••••@•••••

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