A trial to learn how a trial drug called carbetocin works in reducing uncontrollable hunger in people with Prader-Willi syndrome

You may be able to join if

• Informed consent prior to the conduct of any study procedures is required as follows: a. For subjects who are minors: written informed consent will be obtained from the legally acceptable representative (LAR) (or LARs where local regulations require) or from the minor him/herself if deemed able by the Investigator per local regulations. When consent is obtained from the LAR, the subject should provide written or oral assent if deemed able by the Investigator, and according to local regulations. b. For subjects who are of legal age of consent: written informed consent will be obtained from the subject if the subject is not under guardianship and is deemed able by the Investigator. If the subject is under guardianship or deemed not able to provide consent, the subject should provide written or verbal assent if deemed able by the Investigator, and a written informed consent will be obtained from the subject’s LAR(s) according to local regulations. c. The subject’s caregiver provides written consent to participate as an informant in study assessments. The caregiver may or may not be a LAR.
• Caregiver agrees to request and provide medical records to the investigative site.
• Has been on a stable dose of any allowed chronic concomitant medications for at least 3 months prior to the Screening visit. Adjustments in growth hormone dose or medication changes that are not clinically significant in the judgment of the Investigator (i.e., having no reasonable possibility of causing changes in mood, behavior, or appetite, or otherwise affecting study endpoints) are allowed. If the medication was discontinued, the discontinuation occurred at least 2 weeks or 5 half-lives (whichever is greater) prior to Screening.
• This criterion for female subjects varies depending on the location of the subject's clinical site due to local regulatory requirements (or requests). a) In the EU: If the subject is female, she must not be pregnant or breastfeeding. Subjects of childbearing potential should abstain from sexual activity for the duration of the study and for at least 30 days thereafter. If a subject is sexually active or becomes sexually active during the study, she must use a highly effective contraceptive method per Clinical Trials Facilitation and Coordination Group (CTFG) recommendations. The contraceptive method should be used for at least 1 month prior to Baseline, throughout the study, and for at least 30 days thereafter. b) In the UK: : If the subject is female, she must not be pregnant or breastfeeding. Subjects of childbearing potential (including subjects who reach menarche during the study) should abstain from sexual activity for the duration of the study and for at least 30 days thereafter. If a subject is sexually active or becomes sexually active during the study, she must use an intrauterine device (IUD) plus barrier method (diaphragm, cap, or sponge with spermicide), OR she must use one of these acceptable methods of contraception and her partner must use a condom for at least 1 month prior to Baseline, throughout the study, and for at least 30 days thereafter. A female is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. c) In North America: If the subject is female, she must not be pregnant or breastfeeding. Subjects of childbearing potential should abstain from sexual activity for the duration of the study and for at least 30 days thereafter. If a subject is sexually active or becomes sexually active during the study, she must use a non-user-dependent method of contraception (e.g., IUD or implant) or a user-dependent hormonal method of contraception (e.g., injection, oral, transdermal, or intravaginal). The contraceptive method should be used for at least 1 month prior to Baseline, throughout the study, and for at least 30 days thereafter.
• This criterion for male subjects varies depending on the location of the subject’s clinical site due to local regulatory requirements (or requests). a) In the EU: If the subject is male and sexually active, he must use a condom (even if vasectomized) from the time of Screening until 90 days after the last dose of study drug. The male subject’s female partner must use a highly effective contraceptive method per CTFG recommendations. The female partner’s contraceptive method should be used for at least 1 month prior to Baseline, throughout the study, and for at least 30 days thereafter; OR the male subject must not have a female partner of childbearing potential. Subject must also agree not to donate sperm from the time of Screening until 90 days after the last dose of study drug. b) In the UK: If the subject is male and sexually active, he must use a condom (even if vasectomized) from the time of Screening until 90 days after the last dose of study drug. The male subject’s female partner must use either an IUD or a barrier method (e.g., diaphragm, cap, or sponge with spermicide; a female condom in combination with a male condom is not acceptable); OR the male subject must not have a female partner of childbearing potential. Subjects must also agree not to donate sperm from the time of Screening until 90 days after the last dose of study drug. c) In North America: If the subject is male and sexually active, he must use a condom (even if vasectomized) from the time of Screening until 90 days after the last dose of study drug. The male subject’s female partner must use either a non-user-dependent method of contraception (e.g., IUD or implant) or a user-dependent hormonal method of contraception (e.g., injection, oral, transdermal, or intravaginal). The female partner’s contraceptive method should be used for at least 1 month prior to Baseline, throughout the study, and for at least 30 days thereafter; OR the male subject must not have a female partner of childbearing potential. Subject must also agree not to donate sperm from the time of Screening until 90 days after the last dose of study drug.
• Is a male or female 5 to 30 years of age, inclusive, at Screening.