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Evaluation of the safety, tolerability 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 1 mg/cm² | Experimental | Participants received deoxycholic acid 1 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. |
|
| Deoxycholic acid Injection 2 mg/cm² | 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 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores | 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. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Submental Fat Volume | Submental fat volume was measured by magnetic resonance imaging (MRI). | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| Change From Baseline in Submental Fat Thickness |
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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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This study was conducted at 10 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received deoxycholic acid 1 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 | Deoxycholic Acid Injection 2 mg/cm² |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Phosphate buffered saline placebo for injection |
|
Submental fat thickness was measured by magnetic resonance imaging (MRI).
| 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 | San Francisco | California | 94115 | United States |
| Investigational Site | Naperville | Illinois | 60563 | United States |
| Investigational Site | Chestnut Hill | Massachusetts | 02467 | United States |
| Investigational Site | Fridley | Minnesota | 55432 | United States |
| Investigational Site | St Louis | Missouri | 63141 | United States |
| Investigational Site | Omaha | Nebraska | 68144 | United States |
| Investigational Site | Plano | Texas | 75093 | United States |
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. |
| FG002 | 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. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received deoxycholic acid 1 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 | Deoxycholic Acid Injection 2 mg/cm² | 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. |
| BG002 | 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. |
| BG003 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Participants could select more than one category. | Number | participants |
| |||||||||||||||
| Weight | Data available for 40, 43 and 45 participants in each treatment arm respectively. | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index (BMI) | Data available for 40, 43 and 45 participants in each treatment arm 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 |
| |||||||||||||||
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Rating | CR-SMFRS Ratings:
| 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 | Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores | 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. A negative change from Baseline indicates improvement. | Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Submental Fat Volume | Submental fat volume was measured by magnetic resonance imaging (MRI). | Modified intent-to-treat population; LOCF method was used to impute missing data. | Posted | Least Squares Mean | 95% Confidence Interval | mm³ | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Submental Fat Thickness | Submental fat thickness was measured by magnetic resonance imaging (MRI). | Modified intent-to-treat population; LOCF method was used to impute missing data. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |
|
From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).
The safety population included all participants who received at least one injection of study drug.
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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 1 mg/cm² | Participants received deoxycholic acid 1 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. | 0 | 41 | 40 | 41 | ||
| EG001 | Deoxycholic Acid Injection 2 mg/cm² | 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. | 1 | 43 | 40 | 43 | ||
| EG002 | 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. | 0 | 45 | 43 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial hypotension | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site anesthesia | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site edema | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site hematoma | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site hemorrhage | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA v12.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA v12.1 | Systematic Assessment |
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| Injection site paresthesia | General disorders | MedDRA v12.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v12.1 | 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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| 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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| Male |
|
| Hispanic or Latino |
|
| Black or African American |
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| Asian |
|
| Other |
|
| IV - VI |
|
| 3 |
|
There was no formal hypothesis testing and no adjustments for multiple comparisons. |
| ANCOVA |
The ANCOVA model included terms for treatment group and the baseline covariate. |
| 0.003 |
| Difference from placebo |
| -0.5 |
| 2-Sided |
| 95 |
| -0.77 |
| -0.16 |
| No |
| Superiority or Other |
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.
|
|
|
| OG002 |
| 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. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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