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Belly fat melting shot? phase 3 trial begins.
NCT ID NCT07140939
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
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: 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.
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The places running it
13 sites in 2 countries. 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
Encinitas, California, 92024, United States
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Investigational site 10
Nashville, Tennessee, 37215, United States
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Investigational site 11
Pflugerville, Texas, 78660, United States
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Investigational site 12
Vancouver, British Columbia, V5Z1H4, Canada
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Investigational site 13
Toronto, Ontario, M4W2N4, Canada
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Investigational site 2
West Palm Beach, Florida, 33401, United States
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Investigational site 3
Chicago, Illinois, 60610, United States
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Investigational site 4
Baton Rouge, Louisiana, 70809, United States
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Investigational site 5
Hunt Valley, Maryland, 21030, United States
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Investigational site 6
Omaha, Nebraska, 68144, United States
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Investigational site 7
Hackensack, New Jersey, 07601, United States
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Investigational site 8
New York, New York, 10028, United States
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Investigational site 9
Charlotte, North Carolina, 28207, United States
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