Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: Placebo

Drug: NNC9204-1706 A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03095807

U1111-1177-7821 (Other Identifier)

NN9423-4302

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.

Enrollment

34 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator

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 equal to or above 5%
Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and 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