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This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
No study medication was administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants treated with placebo in previous ATX-101 studies |
|
| ATX-101 (1 mg/cm^2) | Experimental | Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies |
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| ATX-101 (2 mg/cm^2) | Experimental | Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies |
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| ATX-101 (4 mg/cm^2) | Experimental | Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
| Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, III, MD, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Clinical Testing Center Beverly Hills |
Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-06-03, ATX-101-07-07, & ATX-101-09-15 were enrolled in this non-treatment follow-up study to further evaluate safety and efficacy.
The objective of this non-treatment, placebo-controlled, 5-year follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ATX-101 (Deoxycholic Acid) Injection | This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ATX-101 (1 mg/cm^2) | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events |
|
| ATX-101 (2 mg/cm^2) | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events |
|
| ATX-101 (4 mg/cm^2) | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events |
|
| Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Mokusiga, Inc | Beverly Hills | California | 90212 | United States |
| Plastic & Reconstructive Surgery | San Francisco | California | 94115 | United States |
| Dermatology Institute of DuPage Medical Group in Naperville | Naperville | Illinois | 60563 | United States |
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Body Aesthetic Research Center | St Louis | Missouri | 63141 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Mei-Heng Tan | Sydney | New South Wales | 2000 | Australia |
| Skin Centre, AHC House | Benowa | Queensland | 4217 | Australia |
| Southeast Dermatology Belmont Specialist Centre | Carina Heights | Queensland | 4152 | Australia |
| T/AS Dermatology Institute of Victoria | South Yarra | Victoria | 3141 | Australia |
| Niagara Falls Dermatology & Skin Care | Niagara Falls | Ontario | L2E 7H1 | Canada |
| Institute of Cosmetic & Laser Surgery | Oakville | Ontario | L6J 7W5 | Canada |
| Toronto Cosmetic Skin Surgery Centre | Toronto | Ontario | M4V 1R1 | Canada |
| Cosmetic Dermatology on Bloor | Toronto | Ontario | M5S 3B4 | Canada |
| The Dermatology Centre | Salford | Manchester | M6 8HD | United Kingdom |
| Cranley Clinic, Harcout House | London | W1G OPN | United Kingdom |
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ATX-101 (Deoxycholic Acid) Injection | This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 |
| BG001 | Placebo | This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Visit 0 (Day 0); date of last visit in the predecessor study to which a participant was originally enrolled. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline weight (kg) | Mean | Standard Deviation | kilogram (kg) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Analysis population included all who received study treatment from a previous study, and who were CR-SMFRS 1-Grade Responders at LTFU Baseline | Posted | Number | percentage of participants | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
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| Primary | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Analysis population included all who received study treatment from a previous study, and who were PR-SMFRS 1-Grade Responders at LTFU Baseline | Posted | Number | percentage of participants | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
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| Primary | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 1-Grade Responders at LTFU Baseline | Posted | Number | percentage of participants | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
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| Primary | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. | Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 2-Grade Responders at LTFU Baseline | Posted | Number | percentage of participants | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |
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Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATX-101 (Deoxycholic Acid) Injection | This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 | 0 | 140 | 3 | 140 | 0 | 140 |
| EG001 | Placebo | This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15 | 1 | 65 | 3 | 65 | 0 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Asymptomatic cystic thyroid mass | Endocrine disorders | MedDRA (14.0) | Systematic Assessment |
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| Third degree heart block | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
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| Patient died of pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thyroid cancer | Endocrine disorders | MedDRA (14.0) | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beta Bowen | Allergan, Inc | 714-246-4446 | Bowen_Beta@allergan.com |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Visit 1 (Month 3) |
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| Visit 2 (Month 6) |
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| Visit 3 (Month 9) |
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| Visit 4 (Month 12) |
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| Visit 5 (Month 18) |
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| Visit 6 (Month 24) |
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| Visit 7 (Month 36) |
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| Visit 8 (Month 48) |
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| Visit 9 (Month 60) |
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