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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 |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 | Little Rock | Arkansas | 72116 | 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 | Los Angeles | California | 90067 | United States |
| Investigational Site | Sacramento | California | 95817 | United States |
| Investigational Site | San Francisco | California | 94115 | United States |
| Investigational Site | Santa Monica | California | 90404 | United States |
| Investigational Site | Englewood | Colorado | 80113 | United States |
| Investigational Site | Coral Gables | Florida | 33146 | United States |
| Investigational Site | Jacksonville | Florida | 32204 | United States |
| Investigational Site | Chicago | Illinois | 60611 | United States |
| Investigational Site | Naperville | Illinois | 60563 | United States |
| Investigational Site | Carmel | Indiana | 46032 | United States |
| Investigational Site | South Bend | Indiana | 46617 | United States |
| Investigational Site | Lutherville | Maryland | 21093 | United States |
| Investigational Site | Clinton Township | Michigan | 48038 | United States |
| Investigational Site | Edina | Minnesota | 55424 | United States |
| Investigational Site | St Louis | Missouri | 63141 | United States |
| Investigational Site | Montclair | New Jersey | 07042 | United States |
| Investigational Site | New York | New York | 10022 | United States |
| Investigational Site | New York | New York | 10065 | United States |
| Investigational Site | White Plains | New York | 10604 | United States |
| Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Investigational Site | High Point | North Carolina | 27262 | United States |
| Investigational Site | Cincinnatti | Ohio | 45255 | United States |
| Investigational Site | Portland | Oregon | 97035 | United States |
| Investigational Site | Austin | Texas | 78759 | United States |
| Investigational Site | Plano | Texas | 75093 | United States |
| Investigational Site | San Antonio | Texas | 78229 | United States |
| Investigational Site | Salt Lake City | Utah | 84117 | United States |
| Investigational Site | Charlottesville | Virginia | 22911 | United States |
| Investigational Site | Calgary | Alberta | T3G0B4 | Canada |
| Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Investigational Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Investigational Site | Oakville | Ontario | Canada |
| Investigational Site | Woodbridge | Ontario | L4L 8E2 | 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 257 participants in each treatment group | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index (BMI) | Data available for 257 participants in each treatment group | 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. | 7 | 258 | 251 | 258 | ||
| 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. | 10 | 256 | 216 | 256 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Hip surgery | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Vaginal operation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | 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 erythema | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Injection site pruritus | 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 warmth | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 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 |
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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 |
Not provided
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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 |
|
|
|