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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002320-83 | EudraCT Number |
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To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with pro-opiomelanocortin (POMC) deficiency or proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity due to rare biallelic or loss-of function mutations at the end of 1 year of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setmelanotide | Experimental | Participants received titrated doses of setmelanotide once daily, by subcutaneous (SC) injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kilograms (kg) weight loss (or at least 5% weight loss if baseline body weight was <100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (~1 year) of treatment at a therapeutic dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setmelanotide | Drug | Once daily SC injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort) | The percentage of participants who met the ≥ 10% weight loss threshold after approximately Week 52 (~1 year) of treatment were analyzed. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal + Supplemental Cohort) | The percentage of participants who met the ≥ 10% weight loss threshold after approximately Week 52 (~1 year) of treatment were analyzed. | Week 52 |
| Mean Percent Change From Baseline in Body Weight at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Meeker, MD | Rhythm Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33137293 | Derived | Clement K, van den Akker E, Argente J, Bahm A, Chung WK, Connors H, De Waele K, Farooqi IS, Gonneau-Lejeune J, Gordon G, Kohlsdorf K, Poitou C, Puder L, Swain J, Stewart M, Yuan G, Wabitsch M, Kuhnen P; Setmelanotide POMC and LEPR Phase 3 Trial Investigators. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020 Dec;8(12):960-970. doi: 10.1016/S2213-8587(20)30364-8. Epub 2020 Oct 30. |
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At screening, a blood sample was obtained for genotyping for mechanisms considered to be possibly related to the safety or efficacy response to the study medication (e.g., other obesity related genes). Complete physical, relevant bloodwork, and other standard assessments were performed.
Participants were enrolled into the pivotal cohort (10 participants) or supplemental cohort (5 participants).
Pivotal cohort: Set of participants under study constituted a collection of detailed clinical case reports with a comprehensive baseline and past medical history assessment and complete clinical efficacy, safety and laboratory evaluations conducted for each participant.
Supplemental cohort: Any additional participants enrolled were included in supplemental cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Setmelanotide | Participants received titrated doses of setmelanotide once daily, by subcutaneous (SC) injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kilograms (kg) weight loss (or at least 5% weight loss if baseline body weight was <100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (~1 year) of treatment at a therapeutic dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titration Period (2 to 12 Weeks) |
| ||||||||||||||||
| Open-Label Period (10 Weeks) |
| ||||||||||||||||
| Double-Blind Withdrawal Period (8 Weeks) |
| ||||||||||||||||
| Open-Label Period (32 Weeks) |
|
The Safety Analysis Set (SAS) Population consisted of participants who received any of the study drug injections and had at least one post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Setmelanotide | Participants received titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was <100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (~1 year) of treatment at a therapeutic dose. |
| 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 Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort) | The percentage of participants who met the ≥ 10% weight loss threshold after approximately Week 52 (~1 year) of treatment were analyzed. | Full Analysis Set (FAS) population included participants who received any of the study drug injections and had at least one baseline assessment (included those who did and did not demonstrate ≥ 5 kg weight loss or 5% of body weight if weight was < 100 kg at baseline over the 12-week open-label treatment period, and proceeded into the double-blind, placebo-controlled withdrawal period). Participants in pivotal cohort were included in the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 52 |
|
From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
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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 titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was <100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (~1 year) of treatment at a therapeutic dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
There was no planned comparison to a randomized placebo group given the rarity of monogenic POMC deficiency obesity. To provide support in assessing setmelanotide treatment in this open-label single-arm trial design, individual participants were evaluated during a double-blind placebo-controlled withdrawal phase in which participants served as their own control to assess effects on weight and reported hunger scores.
| 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 | Jul 24, 2018 | May 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2019 | May 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C579663 | setmelanotide |
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Open-label with an 8 week Double-Blind Placebo-Controlled Withdrawal Period
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During the 8 week double-blind placebo-controlled withdrawal period, participants received 4 weeks of daily setmelanotide and 4 weeks of daily placebo. Participants, investigators, and sites remained blinded as to when placebo treatment was administered.
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| Placebo | Drug | Once daily SC injection |
|
The mean percent change from baseline in body weight at 52 weeks was analyzed. |
| Baseline, Week 52 |
| Mean Percent Change From Baseline in Hunger Score (Worst "Most" Hunger in 24 Hours) at Week 52 | The mean percent change in hunger scores for participants ≥12 years of age with leptin receptor (LEPR) deficiency obesity in treatment with setmelanotide was evaluated. Hunger score ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. | Baseline, Week 52 |
| Percentage of Participants Who Achieved at Least 25% Improvement in Daily Hunger From Baseline | The percentage of participants (≥12 years of age) achieving a ≥25% improvement from baseline in hunger score at Week 52 (i.e., after treatment with setmelanotide for 52 weeks at the therapeutic dose) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. | Baseline, Week 52 |
| Absolute Change From Baseline in Waist Circumference at Week 52 | Waist circumference (centimeters) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. Waist circumference was measured when participants were fasting at approximately the same time at each visit. The absolute change from baseline in waist circumference was assessed. | Baseline, Week 52 |
| Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period | A comparison of weight change was evaluated during the 8 week placebo-controlled withdrawal period for each participant, during which each participant received 4 weeks of placebo and 4 weeks active therapy in a blinded fashion. | Baseline, 8-week withdrawal period (up to ~Week 20) |
| Absolute Score in Daily Hunger Reduction During the Double-Blind Placebo-Controlled Withdrawal Period | The absolute score in daily hunger during the double-blind placebo-controlled withdrawal period (≥12 Years of Age) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. Lower scores represent lower hunger, higher scores represent greater hunger. | 8-week withdrawal period (up to ~Week 20) |
| Mean Percent Change From Baseline in Body Mass Index (BMI) at Week 52 | The mean percent change from baseline in BMI was assessed. | Baseline, Week 52 |
| Area Under the Curve (AUC) Change From Baseline in Oral Glucose, Assessed by the Oral Glucose Tolerance Test (OGTT) | The AUC change from baseline for the OGTT was assessed. The AUC was calculated by the linear trapezoidal method and includes pre-dose and post-dose assessments. At each visit, oral glucose was captured pre-meal, and post-meal at the following times: 30 minutes, 60 minutes, 90 minutes, and 120 minutes. OGTT was not performed for participants with a diagnosis of Type 1 or Type 2 diabetes. | Baseline, Week 52 |
| Change From Baseline in Serum Glucose at Week 52 | Change from baseline in serum glucose at Week 52 was assessed. | Baseline, Week 52 |
| Ghent |
| 9000 |
| Belgium |
| Peel Memorial Hospital | Brampton | Ontario | L6W 2Z8 | Canada |
| Institute of Cardiometabolism and Nutrition / Hopital de la Pitié-Salpêtrière | Paris | 75013 | France |
| Charité Campus Virchow-Klinikum / Institute for Experimental Pediatric Endocrinology | Berlin | 13353 | Germany |
| Hospital Universitario Niño Jesús | Madrid | 28009 | Spain |
| University of Cambridge Metabolic Research Laboratories | Cambridge | CB2 0QQ | United Kingdom |
|
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal + Supplemental Cohort) | The percentage of participants who met the ≥ 10% weight loss threshold after approximately Week 52 (~1 year) of treatment were analyzed. | FAS Population. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 52 |
|
|
|
|
| Secondary | Mean Percent Change From Baseline in Body Weight at Week 52 | The mean percent change from baseline in body weight at 52 weeks was analyzed. | Designated Use Set (DUS) analysis population consisted of participants who received any of the study drug injections, demonstrated ≥ 5 kg weight loss or 5% of body weight if weight was <100 kg at baseline over the 12-week open-label treatment period, and proceeded into the double-blind, placebo-controlled withdrawal period. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 52 |
|
|
|
|
| Secondary | Mean Percent Change From Baseline in Hunger Score (Worst "Most" Hunger in 24 Hours) at Week 52 | The mean percent change in hunger scores for participants ≥12 years of age with leptin receptor (LEPR) deficiency obesity in treatment with setmelanotide was evaluated. Hunger score ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. | Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 52 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved at Least 25% Improvement in Daily Hunger From Baseline | The percentage of participants (≥12 years of age) achieving a ≥25% improvement from baseline in hunger score at Week 52 (i.e., after treatment with setmelanotide for 52 weeks at the therapeutic dose) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. | Participants in the FAS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline, Week 52 |
|
|
|
|
| Secondary | Absolute Change From Baseline in Waist Circumference at Week 52 | Waist circumference (centimeters) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. Waist circumference was measured when participants were fasting at approximately the same time at each visit. The absolute change from baseline in waist circumference was assessed. | Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | centimeters | Baseline, Week 52 |
|
|
|
|
| Secondary | Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period | A comparison of weight change was evaluated during the 8 week placebo-controlled withdrawal period for each participant, during which each participant received 4 weeks of placebo and 4 weeks active therapy in a blinded fashion. | Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | kilograms | Baseline, 8-week withdrawal period (up to ~Week 20) |
|
|
|
| Secondary | Absolute Score in Daily Hunger Reduction During the Double-Blind Placebo-Controlled Withdrawal Period | The absolute score in daily hunger during the double-blind placebo-controlled withdrawal period (≥12 Years of Age) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. Lower scores represent lower hunger, higher scores represent greater hunger. | Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 8-week withdrawal period (up to ~Week 20) |
|
|
|
| Secondary | Mean Percent Change From Baseline in Body Mass Index (BMI) at Week 52 | The mean percent change from baseline in BMI was assessed. | Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 52 |
|
|
|
|
| Secondary | Area Under the Curve (AUC) Change From Baseline in Oral Glucose, Assessed by the Oral Glucose Tolerance Test (OGTT) | The AUC change from baseline for the OGTT was assessed. The AUC was calculated by the linear trapezoidal method and includes pre-dose and post-dose assessments. At each visit, oral glucose was captured pre-meal, and post-meal at the following times: 30 minutes, 60 minutes, 90 minutes, and 120 minutes. OGTT was not performed for participants with a diagnosis of Type 1 or Type 2 diabetes. | Participants in the SAS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | minutes*millimoles/liter (min*mmol/L) | Baseline, Week 52 |
|
|
|
| Secondary | Change From Baseline in Serum Glucose at Week 52 | Change from baseline in serum glucose at Week 52 was assessed. | Participants in the SAS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 52 |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| 15 |
| 15 |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Major Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Panic Attack | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Adrenocortical Insufficiency Acute | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Multiple Allergies | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Discolouration | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection Site Nodule | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Temperature Intolerance | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Spontaneous Penile Erection | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Erection Increased | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood Uric Acid Increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| International Normalised Ratio Increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lip Dry | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Perioral Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Muscle Contracture | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cortisol Deficiency | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Selenium Deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vitamin A Deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | 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.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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