HealthyPhase 1NCT01319916
Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 Into Abdominal Fat Tissue
A Phase 1 study testing ATX-101 in people with Healthy, run by Kythera Biopharmaceuticals at 1 site in United States.
Trial summary
Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 into Abdominal Fat Tissue Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATX-101
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Healthy, non-smoking males and nonpregnant, nonlactating females who are 18 to 65 years of age, inclusive, on Day 1A.
- 2. Body mass index (BMI) of 18.5 to ≤ 30.0 at within 28 days before the dose of study material.
- 3. Stable weight (e.g., approximately ± 10 lbs), in the judgment of the investigator, for at least 3 months before Day 1A.
- 4. Sufficient abdominal tissue surface for which 50 injections spaced on 1 cm grid (4 cm x 9 cm square) can be safely administered into fat tissue.
- 5. Fasting glucose within normal limits (i.e., 75-100 mg/dL) at within 28 days before the dose of study material.
- 6. Fasting hemoglobin A1c within normal limits for the laboratory designated for this trial (e.g., 4 - 5.9%) at within 28 days before the dose of study material.
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- 7. Fasting triglycerides within normal limits for the laboratory designated for this trial (e.g., < 150m/dL) at within 28 days before the dose of study material.
- 8. Fasting cholesterol within normal limits for the laboratory designated for this trial (e.g., < 200 mg/dL) at within 28 days before the dose of study material.
- 9. Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained within 28 days before the beginning of the confinement period and again after admission to the research facility for the confinement period, but before the dose of study material. Females must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
- 10. Negative hepatitis B, hepatitis C, and HIV test results. 11. The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
- 12. The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before Day 1A for which the investigator identifies no clinically significant abnormality.
- 13. Signed informed consent obtained before any study-specific procedure is conducted
Who cannot join
- 1. History of any intervention (e.g., liposuction) or trauma associated with the abdominal area, which in the judgment of the investigator, may affect subject's safety or other evaluations of treatment.
- 2. Subjects who, for any reason, are on active diet, calorie restriction, or attempting to lose weight.
- 3. Blood donation of 500 mL or blood transfusion within 60 days before Day 1A, or plasma donation within 7 days before Day 1A.
- 4. Diagnosis of lipodosis (e.g., Gaucher, Niemann-Pick, or Fabry disease) or other confounding metabolic diseases.
- 5. History of hypertriglyceridemia (triglycerides > 200 mg/dL), hypercholesterolemia (cholesterol > 240 mg/dL), or hyperlipidemia.
- 6. Use of statins (e.g., Vitorin, Lipitor, Lopid) or other lipid-lowering agent (e.g., nicotinic acid) within 28 days or five (5) half-lives, whichever is greater, before Day 1A.
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- 7. History of diabetes or screening results indicative of diabetes. 8. Use of antiglycemic agents at any time before screening. 9. Use of any medication that results in systemic exposure beginning during the screening period.
- 10. Any medical condition (e.g., respiratory, cardiovascular, renal, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction) that would interfere with laboratory or safety assessments, compromise the ability of the subject to undergo study procedures, or compromise the subject's ability to give informed consent.
- 11. Treatment with oral anticoagulants (e.g., warfarin, heparin) within 10 days before Day 1A; anticipated need for agents with anticoagulative effects during the course of the trial.
- 12. History of sensitivity to any components of the study material or topical anesthetics (e.g., lidocaine, benzocaine, novocaine).
- 13. Previous enrollment into this trial or treatment with ATX-101 or agents containing deoxycholate.
- 14. Treatment with an investigational agent within 28 days before Day 1A.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Cooper, M.D. Cetero Research
Fargo, North Dakota, 58104
About this study
Official title: Open-Label Study to Evaluate the Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) Into Abdominal Fat Tissue
Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 into Abdominal Fat Tissue
Read the detailed description
Phase 1, Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) into Abdominal Fat Tissue
- Conditions
- Healthy
- Being tested
- ATX-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101Drug
ATX-101 2mg/cm2
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of ATX-101 on serum lipid and deoxycholate
acute effects of ATX-101 on serum lipid and deoxycholate profile following subcutaneous administration into abdominal fat tissue.
Secondary outcomes (1)
Adipokine levels following subcutaneous administration of ATX-101
To evaluate adipokine levels following subcutaneous administration of ATX-101 into abdominal fat tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patricia Walker, MD, PhD, Study director, Kythera Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319916
- Sponsor's protocol ID
- ATX-101-10-18
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) Into Abdominal Fat Tissue
- ClinicalTrials.gov ID
- NCT01319916
- Acronym / sponsor ID
- ATX-101-10-18
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 into Abdominal Fat Tissue
Detailed description
Phase 1, Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) into Abdominal Fat Tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Healthy, non-smoking males and nonpregnant, nonlactating females who are 18 to 65 years of age, inclusive, on Day 1A.
- 2. Body mass index (BMI) of 18.5 to ≤ 30.0 at within 28 days before the dose of study material.
- 3. Stable weight (e.g., approximately ± 10 lbs), in the judgment of the investigator, for at least 3 months before Day 1A.
- 4. Sufficient abdominal tissue surface for which 50 injections spaced on 1 cm grid (4 cm x 9 cm square) can be safely administered into fat tissue.
- 5. Fasting glucose within normal limits (i.e., 75-100 mg/dL) at within 28 days before the dose of study material.
Key exclusion criteria (12 listed)
- 1. History of any intervention (e.g., liposuction) or trauma associated with the abdominal area, which in the judgment of the investigator, may affect subject's safety or other evaluations of treatment.
- 2. Subjects who, for any reason, are on active diet, calorie restriction, or attempting to lose weight.
- 3. Blood donation of 500 mL or blood transfusion within 60 days before Day 1A, or plasma donation within 7 days before Day 1A.
- 4. Diagnosis of lipodosis (e.g., Gaucher, Niemann-Pick, or Fabry disease) or other confounding metabolic diseases.
- 5. History of hypertriglyceridemia (triglycerides > 200 mg/dL), hypercholesterolemia (cholesterol > 240 mg/dL), or hyperlipidemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATX-101ATX-101 2mg/cm2 | Drug | – |
Primary outcome
Effects of ATX-101 on serum lipid and deoxycholate
acute effects of ATX-101 on serum lipid and deoxycholate profile following subcutaneous administration into abdominal fat tissue.
1 secondary outcome
Adipokine levels following subcutaneous administration of ATX-101
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Walker, MD, PhD study director
Kythera Biopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATX-101 in people with Healthy, run by Kythera Biopharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of ATX-101 on serum lipid and deoxycholate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011.