New Fat-Targeting drug tested in healthy volunteers
NCT ID NCT05234736
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a single injection of CBL-514 in 10 healthy volunteers to see how the body processes it and whether it is safe. Researchers measured drug levels in the blood and monitored for side effects. The goal was to gather basic safety and drug behavior information, not to treat any disease.
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 study will help determine the right dose and safety of CBL-514 for future trials targeting fat reduction.
- What could go wrong
- This is a small, early-phase study in healthy people, not patients. It only looks at drug levels and safety, not effectiveness for any condition.
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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10 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Jun 2022
- 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
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18 to 64 years
- 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/female aged 18 years to 64 years old (at Screening), inclusive. 2. Body mass index (BMI) \>18.5 and \< 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1. 3. Participant has sufficient subcutaneous fat thickness of at least 3.00 cm (30.0 mm) measured by caliper skinfold method around treatment area at Screening and Day 1. 4. Voluntarily signs the Informed Consent Form (ICF) 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, including food and drink restrictions. Exclusion Criteria: 1. Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who are currently pregnant or lactating. Male participants who are not willing to commit to an acceptable contraceptive method. Female participants who are not WOCBP are not required to use contraception. 2. Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation. 3. Participant has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study. 4. Participant has a clinically significant cardiovascular disease and clinically significant abnormal findings in electrocardiogram (ECG). 5. Participant with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator's discretion. 6. Participant with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or participants with active HIV, hepatitis B, or hepatitis C infections at Screening: 7. Participants with positive COVID-19 antigen test at Screening and Day 1. 8. Participants with any hepatic medical condition that, in the opinion of the Investigator, would compromise the participant's ability to undergo study procedures and/or interfere with the assessment of the obtained data. 9. Participants with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and faint or pass out at the sight of blood or a needle. 10. Participant has abnormal skin or local skin conditions at the treatment area, which in the opinion of Investigator, is inappropriate to participate in the study, including but not limited to any of the following: 11. Participant who has the following procedures: 1. Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study, 2. Liposuction to the region to be treated before Screening or during the study, 3. Esthetic procedure e.g., cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study. 12. Participant is undergoing chronic systemic steroid or immunosuppressive therapy. 13. Requiring continual use of the following therapeutic agents during the study: terfenadine, buspirone, fexofenadine, any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. If a participant needs to use the above-mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used for at least 2 days prior to dosing and until 1 day post-dose. 14. Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine). 15. Participants with known allergies or sensitivities to the IP or its components. 16. Participants with liver cirrhosis or with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) \> 3.0 × upper limit of normal (ULN). 17. Participants with any renal impairment, defined as abnormal serum creatinine, and urea \> 1.5 × ULN or estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m2. Participants who are currently on dialysis should be excluded. Participants with an eGFR ≥ 60 and \< 90 mL/min/1.73 m2 at Screening should be evaluated by the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is assessed by the Investigator as not clinically significant or not related to dysfunction, the subjects may be eligible upon the Investigator's assessment. 18. Use of other investigational drug or device within 4 weeks prior to Screening.
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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.
Contacts and locations
Locations
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DermResearch Inc
Austin, Texas, 78759, United States
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