New injection aims to melt belly fat without surgery
NCT ID NCT07608770
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 Hide 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.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSouth Yarra, Victoria, 3141, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.