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The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
No study medication is administered in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATX-101 | Experimental | Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23. |
|
| Placebo | Placebo Comparator | Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-101 | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 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. | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, III, MD, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Medical Associates of La Jolla | San Diego | California | 92121 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33617632 | Derived | Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B. Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials. Aesthet Surg J. 2021 Oct 15;41(11):NP1532-NP1539. doi: 10.1093/asj/sjab100. |
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Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-11-22 and ATX-101-11-23 were enrolled in this non-treatment, double-blind, placebo-controlled follow-up study to further evaluate safety and efficacy.
The objective of this non-treatment, double-blind, placebo-controlled 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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events |
|
| From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment. |
| Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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. | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-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. | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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. | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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. | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| AboutSkin Dermatology and DermSurgery, PC |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Dermatology Research Institute | Coral Gables | Florida | 33146 | United States |
| Stephan Baker MD PA | Coral Gables | Florida | 33146 | United States |
| Baumann Cosmetic and Research Center | Miami | Florida | 33137 | United States |
| Kenneth R. Beer, MD, PA | West Palm Beach | Florida | 33401 | United States |
| Altman Dermatology Associates | Arlington Hts | Illinois | 60005 | United States |
| DeNova Research | Chicago | Illinois | 60611 | United States |
| DuPage Medical Group, Dermatology Institute | Naperville | Illinois | 60563 | United States |
| Callender Center for Clinical Research | Glendale | Maryland | 20769 | United States |
| Aesthetics, Skin Care, Dermatologic Surgery | Rockville | Maryland | 20850 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Shannon Humphrey, MD | Vancouver | V5Z 4E1 | Canada |
| Carruthers Dermatology Centre Inc. | Vancouver | V5Z4E1 | Canada |
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23. |
| COMPLETED |
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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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23. |
| BG001 | Placebo | This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23. |
| 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 | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Fitzpatrick Score | Fitzpatrick skin type is a numerical classification schema for different skin types and tanning abilities. TYPE 1: Pale white skin, blue/hazel eyes, blond/red hair, always burns, never tans. TYPE 2: Fair skin, blue eyes, burns easily, tans poorly. TYPE 3: Darker white skin, tans after initial burn. TYPE 4: Light brown skin, burns minimally, tans easily. TYPE 5: Brown skin, rarely burns, tans darkly easily. TYPE 6: Dark brown or black skin, never burns, always tans darkly. | Count of Participants | Participants |
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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 3 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. | Participants who had at least a 1-grade reduction from baseline on the CRSMFRS (ie, CR-1 responder) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
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| Secondary | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis | Analysis Population: Participants who had at least a 2-grade reduction from baseline on the CR-SMFRS (ie, CR-2 responder) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment. |
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| Secondary | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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: Participants who had at least a 1-grade reduction from baseline in PR-SMFRS (ie, PR-1 responder) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
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| Secondary | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-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: Participants who had at least a 2-grade reduction from baseline in PR-SMFRS (ie, PR-2 responder) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
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| Secondary | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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: Participants who were both CR-1 responders and PR-1 responders (SMFRS-1) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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: Participants who were both CR-2 responders and PR-2 responders (SMFRS-2) at 12-weeks after last treatment in the predecessor studies. | Posted | Number | 95% Confidence Interval | percentage of participants | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment |
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From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23. | 0 | 113 | 5 | 113 | 0 | 113 |
| EG001 | Placebo | This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23. | 0 | 111 | 1 | 111 | 0 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Breast reconstruction | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Ovarian cancer recurrent | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | 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 |
| > 30 to ≤ 50 years |
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| > 50 years |
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| < 50 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| II |
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| III |
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| IV |
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| V |
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| VI |
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| Visit 2 (Year 2) Percentage |
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| Visit 3 (Year 3) Percentage |
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