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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-004107-32 | EudraCT Number |
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Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setmelanotide | Experimental | Participants received setmelanotide once daily (QD) via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and dose escalated up to a maximum dose of 3.0 milligrams (mg) QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setmelanotide | Drug | Setmelanotide for SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment | BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Percentage of Participants Aged ≥6 to <18 Years With ≥0.2 Reduction of BMI Z-Score or Participants Aged ≥18 Years With 5% Reduction of Body Weight From Baseline After 16 Weeks of Setmelanotide Treatment | For participants aged ≥6 to <18 years, a participant's BMI Z-score was considered for the analysis; for participants ≥18 years, a participant's body weight (kg) was considered for the analysis. BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. |
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Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for study participation:
Participant has documented evidence of HO, including:
Participant has either unilateral hypothalamic lesions or bilateral hypothalamic lesions, as assessed by MRI.
Obesity, documented by a body mass index (BMI) ≥35 kilograms/square meter (kg/m^2) for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants 6 to <18 years of age.
Documented increase in BMI (change from pre-surgery baseline in BMI z-score ≥0.2 for participants <18 years of age or BMI >5% for participants >18 years of age) either during the first 6 months following surgery or within 1 year before surgery AND still present at Screening.
More than 6 months after the end of post-tumor treatment, including chemotherapy, surgery, or radiation.
Highly effective contraception throughout the study and for 90 days following the study.
Ability to communicate well with the Investigator, understand and comply with the requirements of the study, and understand and sign the written informed consent, or, for participants aged <18 years, a parent/legal guardian that can sign.
If receiving hormone replacement therapy, the dose of such therapy has remained stable for at least 2 months prior to Screening.
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for study participation:
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| Name | Affiliation | Role |
|---|---|---|
| David Meeker, MD | Rhythm Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38697184 | Background | Roth CL, Scimia C, Shoemaker AH, Gottschalk M, Miller J, Yuan G, Malhotra S, Abuzzahab MJ. Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial. Lancet Diabetes Endocrinol. 2024 Jun;12(6):380-389. doi: 10.1016/S2213-8587(24)00087-1. Epub 2024 Apr 30. |
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Of the 19 participants screened, 18 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Setmelanotide | Participants received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and dose escalated up to a maximum dose of 3.0 milligrams (mg) QD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set included all participants who received at least 1 dose of setmelanotide and had baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Setmelanotide | Participants received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and dose escalated up to a maximum dose of 3.0 mg QD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment | BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to 16 weeks |
|
From first dose of study drug up to Day 141
Participants in the Safety Analysis Set were analyzed.
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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 | Setmelanotide | Participants received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and dose escalated up to a maximum dose of 3.0 mg QD. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium difficile colitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhythm Clinical Trials | Rhythm Pharmaceuticals, Inc. | 857-264-4280 | clinicaltrials@rhythmtx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2021 | Jun 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2022 | Jun 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050035 | Sexual Infantilism |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C579663 | setmelanotide |
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| Baseline to Week 16 |
| Percentage of Participants Aged ≥6 to <18 Years With ≥0.2 Reduction of BMI Z-Score From Baseline After 16 Weeks of Setmelanotide Treatment | BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline to 16 weeks |
| Percentage of Participants Aged ≥18 Years With ≥5% Reduction of Body Weight From Baseline After 16 Weeks of Setmelanotide Treatment | Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline to Week 16 |
| Change From Baseline in Waist Circumference in Participants Aged ≥18 Years After 16 Weeks of Setmelanotide Treatment | Waist circumference was measured after participants had fasted for at least 8 hours and at approximately the same time at each visit. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline, Week 16 |
| Change From Baseline in Daily Hunger Questionnaire Score in Participants Aged <12 Years After 16 Weeks of Setmelanotide Treatment | Daily Hunger Questionnaire for participants <12 years of age: Three aspects of hunger (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) were assessed daily using a pictorial (smiley face) version of the Likert rating scale with scores from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible. Responses were recorded in the electronic diary. Each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged to calculate a total score ranging from 0 (not hungry at all) to 4 (hungriest possible) with higher score indicating more hunger. Baseline daily hunger score was calculated as the average of 7 days prior to Baseline visit. | Baseline, Week 16 |
| Change From Baseline in Daily Hunger Questionnaire Scores in Participants Aged ≥12 Years After 16 Weeks of Setmelanotide Treatment | Daily Hunger Questionnaire for participants ≥12 years of age: Three aspects of hunger (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) were assessed daily using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible. The responses to the Daily Hunger Questionnaire were recorded in the electronic diary. Baseline daily hunger score was calculated as the average of 7 days prior to Baseline visit. | Baseline, Week 16 |
| Number of Participants With Shift From Baseline in Global Hunger Questionnaire Score to Week 16 in Participants Aged < 12 Years | Parents or caregivers of participants <12 years old answered the Caregiver Reported Global Hunger Question for participants who were <12 years old. The following question was asked: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; and Extremely hungry. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline, Week 16 |
| Number of Participants With Shift From Baseline in Global Hunger Questionnaire Score to Week 16 in Participants Aged ≥12 Years | Global Hunger Questionnaire for participants ≥12 years of age. The following question was asked: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; and Severe hunger. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Baseline, Week 16 |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence or clinically significant worsening of an existing condition associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. | From first dose of study drug up to Day 141 |
| Gainesville |
| Florida |
| 32610-0296 |
| United States |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | United States |
| Vanderbilt University School of Medicine | Nashville | Tennessee | 37232 | United States |
| Seattle Children's Research Institute | Seattle | Washington | 98101 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms/square meter (kg/m^2) |
|
| Body Weight | Mean | Standard Deviation | kilograms (kg) |
|
| BMI Z-Score | The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline. | Participants in the Full Analysis Set with available data were analyzed. | Mean | Standard Deviation | z-score |
|
| Waist Circumference | Mean | Standard Deviation | centimeters (cm) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Composite Percentage of Participants Aged ≥6 to <18 Years With ≥0.2 Reduction of BMI Z-Score or Participants Aged ≥18 Years With 5% Reduction of Body Weight From Baseline After 16 Weeks of Setmelanotide Treatment | For participants aged ≥6 to <18 years, a participant's BMI Z-score was considered for the analysis; for participants ≥18 years, a participant's body weight (kg) was considered for the analysis. BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
|
|
|
|
| Secondary | Percentage of Participants Aged ≥6 to <18 Years With ≥0.2 Reduction of BMI Z-Score From Baseline After 16 Weeks of Setmelanotide Treatment | BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m^2. The BMI Z-score indicated the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score indicates a reduction in BMI from Baseline whereas an increase of BMI-Z score indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to 16 weeks |
|
|
|
|
| Secondary | Percentage of Participants Aged ≥18 Years With ≥5% Reduction of Body Weight From Baseline After 16 Weeks of Setmelanotide Treatment | Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Waist Circumference in Participants Aged ≥18 Years After 16 Weeks of Setmelanotide Treatment | Waist circumference was measured after participants had fasted for at least 8 hours and at approximately the same time at each visit. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cm | Baseline, Week 16 |
|
|
|
| Secondary | Change From Baseline in Daily Hunger Questionnaire Score in Participants Aged <12 Years After 16 Weeks of Setmelanotide Treatment | Daily Hunger Questionnaire for participants <12 years of age: Three aspects of hunger (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) were assessed daily using a pictorial (smiley face) version of the Likert rating scale with scores from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible. Responses were recorded in the electronic diary. Each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged to calculate a total score ranging from 0 (not hungry at all) to 4 (hungriest possible) with higher score indicating more hunger. Baseline daily hunger score was calculated as the average of 7 days prior to Baseline visit. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
|
|
|
| Secondary | Change From Baseline in Daily Hunger Questionnaire Scores in Participants Aged ≥12 Years After 16 Weeks of Setmelanotide Treatment | Daily Hunger Questionnaire for participants ≥12 years of age: Three aspects of hunger (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) were assessed daily using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible. The responses to the Daily Hunger Questionnaire were recorded in the electronic diary. Baseline daily hunger score was calculated as the average of 7 days prior to Baseline visit. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
|
|
|
| Secondary | Number of Participants With Shift From Baseline in Global Hunger Questionnaire Score to Week 16 in Participants Aged < 12 Years | Parents or caregivers of participants <12 years old answered the Caregiver Reported Global Hunger Question for participants who were <12 years old. The following question was asked: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; and Extremely hungry. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Week 16 |
|
|
|
| Secondary | Number of Participants With Shift From Baseline in Global Hunger Questionnaire Score to Week 16 in Participants Aged ≥12 Years | Global Hunger Questionnaire for participants ≥12 years of age. The following question was asked: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; and Severe hunger. Baseline was defined as the most recent measurement prior to the first administration of study drug. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Count of Participants | Participants | Baseline, Week 16 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence or clinically significant worsening of an existing condition associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. | Participants in the Safety Analysis Set were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug up to Day 141 |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| 18 |
| 18 |
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Erection increased | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment | This denominator includes only the male participants in the group (N = 11). |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Type V hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Administration site cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007006 | Hypogonadism |
| Title | Measurements |
|---|---|
|
|
| Extremely hungry (Baseline) - Not hungry at all (Week 16) |
|
| Not hungry at all (Baseline) - A little hungry (Week 16) |
|
| A little hungry (Baseline) - A little hungry (Week 16) |
|
| Moderately hungry (Baseline) - A little hungry (Week 16) |
|
| Extremely hungry (Baseline) - A little hungry (Week 16) |
|
| Not hungry at all (Baseline) - Moderately hungry (Week 16) |
|
| A little hungry (Baseline) - Moderately hungry (Week 16) |
|
| Moderately hungry (Baseline) - Moderately hungry (Week 16) |
|
| Extremely hungry (Baseline) - Moderately hungry (Week 16) |
|
| Not hungry at all (Baseline) - Extremely hungry (Week 16) |
|
| A little hungry (Baseline) - Extremely hungry (Week 16) |
|
| Moderately hungry (Baseline) - Extremely hungry (Week 16) |
|
| Extremely hungry (Baseline) - Extremely hungry (Week 16) |
|
| Title | Measurements |
|---|---|
|
| Severe hunger (Baseline) - No hunger (Week 16) |
|
| No hunger (Baseline) - Mild hunger (Week 16) |
|
| Mild hunger (Baseline) - Mild hunger (Week 16) |
|
| Moderate hunger (Baseline) - Mild hunger (Week 16) |
|
| Severe hunger (Baseline) - Mild hunger (Week 16) |
|
| No hunger (Baseline) - Moderate hunger (Week 16) |
|
| Mild hunger (Baseline) - Moderate hunger (Week 16) |
|
| Moderate hunger (Baseline) - Moderate hunger (Week 16) |
|
| Severe hunger (Baseline) - Moderate hunger (Week 16) |
|
| No hunger (Baseline) - Severe hunger (Week 16) |
|
| Mild hunger (Baseline) - Severe hunger (Week 16) |
|
| Moderate hunger (Baseline) - Severe hunger (Week 16) |
|
| Severe hunger (Baseline) - Severe hunger (Week 16) |
|