Table 2.

Key inclusion and exclusion criteria.

Inclusion criteria	•Clinical diagnosis of BBS [8] or Alström syndrome [9]
	•≥6 years of agea
	•BMI ≥30 kg/m2 (participants aged ≥16 years) or weight >97th percentile for age and sex (participants aged 6–15 years)
Exclusion criteria	•Recent (within 2 months) intensive diet and/or exercise regimen that has resulted in >2% weight loss
	•Use of any medication that is approved to treat obesity within 3 months of randomization
	•Prior gastric bypass surgery resulting in weight loss of >10% with no clear evidence of weight regain
	•HbA1c >9.0% at screening
	•Close family (ie, participant, parents, or siblings) history of skin cancer or melanoma, or history of oculocutaneous albinism
	•Significant dermatologic findings relating to melanoma or premelanoma skin lesions

BBS, Bardet-Biedl syndrome; BMI, body mass index; HbA_1c, glycated hemoglobin.

^aIt was planned that a maximum of 6 participants under the age of 12 years would be initially enrolled into the pivotal cohort.