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Belly fat melting shot? phase 3 trial begins.

NCT ID NCT07140939

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether an injection called CBL-514 can safely reduce abdominal fat. 300 adults with moderate to severe belly fat will receive either the drug or a placebo. The study measures fat loss by MRI and patient ratings over time.

What this could mean

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

Active substance
CBL-514 injection
What this could lead to
If it works, this could offer a non-surgical way to reduce stubborn belly fat.
What could go wrong
This is an early Phase 3 trial, so results are not yet known. The treatment may not work better than placebo, and side effects are possible.
Why investors are watching

Caliway Biopharmaceuticals is running a phase 3 trial of CBL-514, an injected drug meant to reduce belly fat, against a placebo in 300 participants. For a small company, this late-stage readout is a major test of whether its lead product works and is safe, which could shape the company's future.

If it works: If the trial shows CBL-514 reduces abdominal fat better than placebo with acceptable safety, Caliway could have a marketable product for a common cosmetic concern. That result might attract partners or buyers.

If it fails: Phase 3 trials often fail, and a negative or unclear result could set the drug back or end it. A delay in the readout would also leave the company without a key catalyst for a long time.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 years and older

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. Male or female, aged ≥ 18 years old. 2. Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg. 3. Participant has moderate or severe abdominal fat as assessed by the Investigator on the CR-AFRS and by the participant on the PR-AFRS. 4. Participant maintained a stable lifestyle. 5. Voluntarily signs the Informed Consent Form and is physically and mentally capable of participating in the study, and willing to adhere to study procedures. Exclusion Criteria 1. Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method, or who is currently pregnant or lactating. Male participant who is not committing to using condom consistently and refraining from sperm donation. 2. Participant who has impeded coagulation or platelet aggregation. 3. Participant has delayed wound healing or poorly controlled diabetes. 4. Participant has active malignancies or is currently being evaluated for a possible malignancy. 5. Participant has a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experiences vasovagal syncope and faints at the sight of blood or a needle. 6. Participant has a visible Panniculus on the abdomen in standing position. 7. Participant has severe abdominal visceral fat. 8. Participant has skin conditions, which would pose risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation. 9. Participant has undergone the procedures at the treatment area that may affect IP administration. 10. Participant with contraindications to MRI imaging. 11. Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists. 12. Participant is undergoing long-term systemic steroid or immunosuppressive therapy which may affect the treatment area. 13. Participant is taking or will take any medication that is known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index. 14. Participant with history of hypersensitivity to local anesthesia. 15. Participant with known allergies or significant adverse reaction to the IP. 16. Participant with liver cirrhosis or abnormal liver function, or with any hepatic condition that interferes with the safety or efficacy assessments. 17. Participant with any renal impairment. 18. Participant has received any investigational product. 19. Participant considered to be unreliable or incapable of complying with the requirements of the protocol.

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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

    13 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

  • Investigational site 1

    Encinitas, California, 92024, United States

  • Investigational site 10

    Nashville, Tennessee, 37215, United States

  • Investigational site 11

    Pflugerville, Texas, 78660, United States

  • Investigational site 12

    Vancouver, British Columbia, V5Z1H4, Canada

  • Investigational site 13

    Toronto, Ontario, M4W2N4, Canada

  • Investigational site 2

    West Palm Beach, Florida, 33401, United States

  • Investigational site 3

    Chicago, Illinois, 60610, United States

  • Investigational site 4

    Baton Rouge, Louisiana, 70809, United States

  • Investigational site 5

    Hunt Valley, Maryland, 21030, United States

  • Investigational site 6

    Omaha, Nebraska, 68144, United States

  • Investigational site 7

    Hackensack, New Jersey, 07601, United States

  • Investigational site 8

    New York, New York, 10028, United States

  • Investigational site 9

    Charlotte, North Carolina, 28207, United States

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