A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

NCT03787225 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9838-4483U1111-1219-7303
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose

  Measured in h\*nmol/L

  From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Secondary Outcomes (2)

• Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma

  From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

• Number of treatment emergent adverse events (TEAEs)

  From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)

Study Arms (4)

NNC0174-0833 (0.3 mg)

EXPERIMENTAL

Participants will receive single dose of NNC0174-0833

Drug: NNC0174-0833

NNC0174-0833 (0.9 mg)

EXPERIMENTAL

Participants will receive single dose of NNC0174-0833

Drug: NNC0174-0833

NNC0174-0833 (1.8 mg)

EXPERIMENTAL

Participants will receive single dose of NNC0174-0833

Drug: NNC0174-0833

Placebo (NNC0174-0833)

PLACEBO COMPARATOR

Participants will receive placebo (NNC0174-0833)

Drug: Placebo (NNC0174-0833)

Interventions

NNC0174-0833 DRUG

Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.

NNC0174-0833 (0.3 mg); NNC0174-0833 (0.9 mg); NNC0174-0833 (1.8 mg)

Placebo (NNC0174-0833) DRUG

Participants will receive NNC0174-0833 matched placebo subcutaneously.

Placebo (NNC0174-0833)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
• For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
• For Caucasian subjects, self-reported European descent or white Latin-American descent.
• Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Body weight between 60 and 110 kg (both inclusive) at screening

You may not qualify if:

• Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner\[s\] of childbearing potential), who is 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 less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: January 7, 2019
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)