DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway

Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1

Time frame · Baseline to Week 16

BMI was calculated using participant's weight and height assessments, using the following formula: BMI = Kilogram (kg)/ square meter (m\^2). A significant clinically meaningful response was defined as achieving a ≥5% reduction in BMI from Baseline. Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Mean Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype

Time frame · Baseline, Week 16

BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Mean Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype

Time frame · Baseline, Week 16

BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2 Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Percent Change in BMI From Baseline to the End of Stage 1 in All Participants, Per Genotype

Time frame · Baseline, Week 16

BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2 Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Percent Change in BMI From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype

Time frame · Baseline, Week 16

BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2 Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Mean Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype

Time frame · Baseline, Week 16

Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Percent Change in Body Weight From Baseline to the End of Stage 1 in Participants ≥18 Years Old, Per Genotype

Time frame · Baseline, Week 16

Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.

Mean Change in BMI Z-score From Baseline to the End of Stage 1 in Participants <18 Years Old, Per Genotype

Time frame · Baseline, Week 16

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 last available measurement taken prior to the start of treatment Stage 1 administration.

Percent Change in the Weekly Average of the Daily Maximal Hunger Score From Baseline to the End of Stage 1 in Participants ≥12 Years Old, Per Genotype

Time frame · Baseline, Week 16

Daily Hunger Questionnaire for participants ≥12 years of age is self-administered questionnaire and comprises three items. For the assessment of this endpoint, maximal hunger was corresponding to the following question: In the last 24 hours, how hungry did you feel when you were the most hungry? The response was scored separately and averaged on weekly basis. Participants rated their hunger on an 11-point numeric rating scale ranging from 0 to 10 (0 = not hungry at all, and 10 = hungriest possible). Weekly average at Week 16 was defined as average of the available score values within 7 days in Week 16. Baseline was defined as the average of the available score values within 7 days before or on the stage 1 open-label treatment. Results are reported by overall participant results and by specific gene cohort.

Number of Participants ≥12 Years Old, Who Achieved a ≥2 Point Reduction From Baseline to the End of Stage 1 in the Weekly Average of the Daily Maximal Hunger Score, Per Genotype

Time frame · Baseline, Week 16

Daily Hunger Questionnaire for participants ≥12 years of age is self-administered questionnaire and comprises three items. For the assessment of this endpoint, maximal hunger was corresponding to the following question: In the last 24 hours, how hungry did you feel when you were the most hungry? The response was scored separately and averaged on weekly basis. Participants rated their hunger on an 11-point numeric rating scale ranging from 0 to 10 (0 = not hungry at all, and 10 = hungriest possible). Weekly average at Week 16 was defined as average of the available score values within 7 days in Week 16. Baseline was defined as the average of the available score values within 7 days before or on the stage 1 open-label treatment. Results are reported by overall participant results and by specific gene cohort.