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To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic acid injection | Drug | Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Composite 1-grade Response | A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| Percentage of Participants Who Achieved a Composite 2-grade Response | A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response | An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, MD, PhD | Kythera Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site |
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The study was performed at 35 investigational centers in the United States (US) and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Phosphate buffered saline placebo for injection |
|
| Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Investigational Site | Beverly Hills | California | 90212 | United States |
| Investigational Site | Irvine | California | 92697 | United States |
| Investigational Site | Los Angeles | California | 90201 | United States |
| Investigational Site | Oceanside | California | 92056 | United States |
| Investigational Site | San Diego | California | 92117 | United States |
| Investigational Site | San Diego | California | 92121 | United States |
| Investigational Site | New Haven | Connecticut | 06511 | United States |
| Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| Investigational Site | Miami Beach | Florida | 33140 | United States |
| Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Investigational Site | Atlanta | Georgia | 30342 | United States |
| Investigational Site | Snellville | Georgia | 30078 | United States |
| Investigational Site | Arlington | Illinois | 60005 | United States |
| Investigational Site | Chicago | Illinois | 60611 | United States |
| Investigational Site | Evansville | Indiana | 47713 | United States |
| Investigational Site | Louisville | Kentucky | 40217 | United States |
| Investigational Site | Glenn Dale | Maryland | 20769 | United States |
| Investigational Site | Hunt Valley | Maryland | 21030 | United States |
| Investigational Site | Rockville | Maryland | 20850 | United States |
| Investigational Site | West Bloomfield | Michigan | 48322 | United States |
| Investigational Site | Fridley | Minnesota | 55432 | United States |
| Investigational Site | Omaha | Nebraska | 68144 | United States |
| Investigational Site | New York | New York | 10028 | United States |
| Investigational Site | New York | New York | 10029 | United States |
| Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Investigational Site | Nashville | Tennessee | 37203 | United States |
| Investigational Site | Nashville | Tennessee | 37215 | United States |
| Investigational Site | Charlottesville | Virginia | 22911 | United States |
| Investigational Site | Spokane | Washington | 99204 | United States |
| Investigational Site | Peterborough | Ontario | K9J 1Z2 | Canada |
| Investigational Site | Toronto | Ontario | M5R 3N8 | Canada |
| Investigational Site | Toronto | Ontario | M5S 3B4 | Canada |
| Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| Investigational Site | Vancouver, B.C. | V5Z4E1 | Canada |
Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| BG001 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Data available for 256 and 249 participants in each treatment group respectively | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index (BMI) | Data available for 256 and 249 participants in each treatment group respectively | Mean | Standard Deviation | kg/m² |
| ||||||||||||||
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:
| Number | participants |
|
| 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 Who Achieved a Composite 1-grade Response | A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. | Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process. | Posted | Number | percentage of participants | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
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| Primary | Percentage of Participants Who Achieved a Composite 2-grade Response | A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. | Intent-to-treat population; missing values were imputed using a multiple imputation process. | Posted | Number | percentage of participants | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response | An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers. | The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used. | Posted | Number | percentage of participants | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement. | Intent-to-treat population; missing values were imputed using a multiple imputation process. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
|
From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
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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 | Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 6 | 257 | 246 | 257 | ||
| EG001 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 12 | 248 | 196 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urethral disorder | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site anaesthesia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Kythera | clinical_trials@kythera.com |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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| 51 - 65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaskan Native |
|
| Native Hawaiian or Pacific Islander |
|
| Multiple |
|
| Other |
|
| Non-Hispanic or Latino |
|
| IV - VI |
|
| No |
| Superiority or Other |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|