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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002005-36 | EudraCT Number |
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To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setmelanotide | Drug | Once daily subcutaneous 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 (responders) 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 (responders) after approximately Week 52 (~1 year) of treatment were analyzed. | Week 52 |
| Mean Percent Change From Baseline in Body Weight |
Not provided
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 |
|---|---|---|---|---|---|---|
| Markham Stouffville Hospital | Markham | Ontario | L3P 7P3 | Canada | ||
| Institute of Cardiometabolism and Nutrition / Pitié-Salpêtrière Hospital |
| 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 (11 participants) or supplemental cohort (4 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 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) |
|
Not provided
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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, Categorical | Count of 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 Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort) | The percentage of participants who met the ≥10% weight loss threshold (responders) after approximately Week 52 (~1 year) of treatment were analyzed. | The full analysis set (FAS) consisted of participants who received any of the study drug injections and at least one baseline assessment (included those who did and did not demonstrate ≥5 kg weight loss or 5% of body weight if weight is <100 kg at baseline over the initial12-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 placebo & setmelanotide groups combined as one group per planned analysis.
Not provided
| 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 |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
Based on meetings with the Federal Drug Administration (FDA), the structure of the endpoints was slightly different in the statistical analysis plan (SAP) and the protocol.
In addition, there was no planned comparison to a randomized placebo group given the rarity of monogenic LEPR deficiency obesity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhythm Clinical Trials | Rhythm Pharmaceuticals, Inc. | 857-264-4280 | clinicaltrials@rhythmtx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2018 | Apr 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2019 | Apr 5, 2023 | SAP_001.pdf |
Not provided
Not provided
| 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 |
Not provided
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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.
Not provided
| Placebo | Drug | Once daily subcutaneous injection |
|
The mean percent change from baseline in body weight at 52 weeks was analyzed. |
| Baseline and Week 52 |
| Mean Percent Change From Baseline in Hunger Score ('Most Hunger') | 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. | Baseline and Week 52 |
| Percentage of Participants Achieving 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. | Baseline and Week 52 |
| Absolute Change From Baseline in Waist Circumference | Waist circumference (cm) 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 and 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 and Week 8 of withdrawal period |
| Absolute Daily Hunger Reduction Score During the Double-Blind Placebo-Controlled Withdrawal Period | The absolute score in daily hunger reduction 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. | Week 8 of withdrawal period |
| Mean Percent Change From Baseline in Body Mass Index | The mean percent change from baseline in body mass index (BMI) was assessed. | Baseline and Week 52 |
| Change From Baseline in Glucose Parameters | Glucose parameters included glucose, glycated hemoglobin (HbA1c) and Oral glucose tolerance test (OGTT). Data is planned to be reported only for change from baseline in glucose levels. | Baseline and Week 52 |
| Paris |
| 75013 |
| France |
| University of Ulm | Ulm | Germany |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Hôpital Félix GUYON | Saint-Denis | 97405 | Reunion |
| University of Cambridge Metabolic Research Laboratories | Cambridge | CB2 0QQ | United Kingdom |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 (responders) 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 | The mean percent change from baseline in body weight at 52 weeks was analyzed. | The Designated Use Set (DUS) 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] during the initial 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 and Week 52 |
|
|
|
|
| Secondary | Mean Percent Change From Baseline in Hunger Score ('Most Hunger') | 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. | DUS Population. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 52 |
|
|
|
|
| Secondary | Percentage of Participants Achieving 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. | FAS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline and Week 52 |
|
|
|
|
| Secondary | Absolute Change From Baseline in Waist Circumference | Waist circumference (cm) 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. | DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | Centimeter | Baseline and 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. | DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | Kilogram | Baseline and Week 8 of withdrawal period |
|
|
|
| Secondary | Absolute Daily Hunger Reduction Score During the Double-Blind Placebo-Controlled Withdrawal Period | The absolute score in daily hunger reduction 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. | DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 8 of withdrawal period |
|
|
|
| Secondary | Mean Percent Change From Baseline in Body Mass Index | The mean percent change from baseline in body mass index (BMI) was assessed. | DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 52 |
|
|
|
|
| Secondary | Change From Baseline in Glucose Parameters | Glucose parameters included glucose, glycated hemoglobin (HbA1c) and Oral glucose tolerance test (OGTT). Data is planned to be reported only for change from baseline in glucose levels. | The Safety Analysis Set (SAS) was defined as all participants who received any study drug injections at least one post-dose safety assessment. Participants with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis. | Posted | Mean | Standard Deviation | millimole per liter | Baseline and Week 52 |
|
|
|
| 1 |
| 15 |
| 3 |
| 15 |
| 15 |
| 15 |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Leading to event |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastric Banding Reversal | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Eye naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | 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 |
|
| Injection site bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site atrophy | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Medical device pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Medical device site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Xerosis | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depression | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Suicidal ideation | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Affect lability | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fear of injection | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Illusion | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Spontaneous penile erection | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vaginal haemorrhage | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood creatine phosphokinase abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood follicle stimulating hormone increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood luteinising hormone increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Insulin tolerance test abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Cardiac flutter | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sleep paralysis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Presyncope | 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 |
|
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tic | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gingival discolouration | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hair growth rate abnormal | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lentigo | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Melanocytic naevus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | 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 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypogonadism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vitamin A deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Arthritis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Injection site abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | 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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