First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: NNC0194-0499; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03015207

NN9499-4277

U1111-1181-9045 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

Enrollment: 56 patients

Sex: Male

Ages: 22 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

• Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
• Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) 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) 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 (visit 1) until 3 months following administration of the investigational medical product
• Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

NNC0194-0499

Experimental group

Description:

Injected s.c. /subcutaneously (under the skin)

Treatment:

Drug: NNC0194-0499

Placebo

Placebo Comparator group

Description:

Injected s.c. /subcutaneously (under the skin)

Treatment:

Drug: Placebo