A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: NNC9204-1177

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NN9277-4258

U1111-1173-8190 (Other Identifier)

Details and patient eligibility

About

Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity

Enrollment

49 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male, aged 18-55 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening

Exclusion criteria

Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above or equal to 5%
Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product