New injection melts belly fat in clinical trial
NCT ID NCT07608757
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an injection called CBL-514 to see if it can safely reduce belly fat. About 250 adults with extra abdominal fat will receive either the injection or a placebo. The goal is to measure fat loss using MRI and doctor ratings.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 greater than Grade 1 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. * Participant has complied with Stage 1 study procedures and requirements. 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Investigational Site 1
South Yarra, Victoria, 3141, Australia
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