Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New injection aims to melt belly fat without surgery

NCT ID NCT07608770

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 2b trial tests an injection called CBL-514 to see if it can safely reduce abdominal fat. About 250 adults with moderate to high belly fat will receive either the drug or a placebo. The main goal is to measure fat reduction using MRI scans 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 successful, this could offer a non-surgical option to reduce belly fat in people with moderate to high abdominal fat.
What could go wrong
This is an early phase 2b trial, so results are not yet proven. The treatment may not work better than placebo, and side effects are still being studied.
Why investors are watching

Caliway Biopharmaceuticals is testing its drug CBL-514 in a phase 2b trial with 250 participants to see if injections reduce belly fat compared to a placebo. For a small company, this readout is a key checkpoint because a clear result could shape the drug's future and the company's value.

If it works: If the trial shows CBL-514 safely reduces abdominal fat, Caliway could move the drug toward later-stage testing and possibly a market entry in the cosmetic or medical fat-reduction field.

If it fails: If the drug fails to beat placebo or shows safety problems, the trial could end or stall, and Caliway would face a setback with no approved product. Trials at this stage often fail, so the outcome is uncertain.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 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: * Male or female, aged ≥ 18 years old. * Body mass index (BMI) \> 18.5 and \< 30 kg/m2 and body weight ≥ 50 kg. * CR-AFRS and PR-AFRS score: participant has Grade 3 or Grade 4 abdominal fat as assessed both by the Investigator on the CR-AFRS and by the participant on the PR-AFRS. * Participant maintained a stable lifestyle. * Voluntarily signs the Informed Consent Form and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures. Exclusion Criteria: * Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method and refraining from ova donation from the time of Screening and throughout the study until 90 days after the last dose of IP, or who is currently pregnant or lactating. Fertile male participant who is not willing to commit to an acceptable contraceptive method and refraining from sperm donation from the time of the first dose of IP and throughout the study until 90 days after the last dose of IP. * Participant was diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications. * Participant has delayed wound healing or poorly controlled diabetes. * Participant has a history of active malignancy within 3 years before Screening, or is currently being evaluated for a possible malignancy. * Participant has a history of trypanophobia, the extreme fear of medical procedures involving injections or needles. * Participant has a visible Panniculus (folding fat) or visible folds of skin on the abdomen in a standing position. * Participant has severe or very severe abdominal visceral fat. * Participant has skin conditions which, in the opinion of the Investigator, would pose a risk to the participant if receiving the IP or interfere with the safety or efficacy evaluation. * Participant has undergone the following procedures: a. Surgery that caused scar tissue at the treatment area; b. Previous history of abdominoplasty or abdominal liposuction within the treatment area; c. Aesthetic procedure for body contouring or fat reduction at the treatment area within 12 months before Screening; d. SC injection or transdermal application of medication at the treatment area within 4 weeks before Screening. * Participant with contraindications to magnetic resonance imaging (MRI) * Participant is on prescription or over-the-counter weight reduction medication, weight reduction programs, or taking oral or injectable GLP-1 agonists (eg, semaglutide, tirzepatide, liraglutide, etc.) within 6 months before Screening. * Participant is undergoing long-term systemic steroid or immunosuppressive therapy * Participant is taking or will take any medication that is a known strong inhibitor or inducer of CYP1A2 enzymes, sensitive CYP1A2 substrates, or medication with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the safety or efficacy evaluation of the IP or pose undue risk to the participant. * Participant with history of hypersensitivity to local anesthesia (eg, lidocaine). * Participant with known allergies or significant adverse reaction to the IP or any of its ingredients. * Participant with liver cirrhosis or abnormal liver function test at Screening * Participant currently on dialysis or with any renal impairment at Screening * Participant has received any investigational product (including a device) within 3 months before Screening. * Participant has an unstable condition (eg, psychiatric disorder, history of substance abuse within 3 years before Screening) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol (eg, visit schedule, off-site MRI measurement). * Participant with a known history or current diagnosis of body dysmorphic disorder or eating disorders. * Participant has a history of vasovagal syncope.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Subcutaneous fat are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Investigational Site 1

    RECRUITING

    South Yarra, Victoria, 3141, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.