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

NCT02941042 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9277-4258U1111-1173-8190
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  From time of dosing (day 1) until completion of the follow-up visit (day 39)

Secondary Outcomes (5)

• Area under the NNC9204-1177 serum concentration-time curve

  From 0 to 168 hours after a single s.c. dose

• Maximum serum concentration of NNC9204-1177

  From time of dosing (day 1) until completion of the follow-up visit (day 39)

• Time to maximum serum concentration of NNC9204-1177

  From time of dosing (day 1) until completion of the follow-up visit (day 39)

• Change in body weight

  Day 1, day 39

• Change in QT interval corrected using the Fridericia formula (QTcF)

  Day 1, day 39

Study Arms (2)

NNC9204-1177

EXPERIMENTAL

Drug: NNC9204-1177

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NNC9204-1177 DRUG

A single dose administered subcutaneously ( s.c. under the skin)

NNC9204-1177

Placebo DRUG

A single dose administered subcutaneously ( s.c. under the skin)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 21, 2016
• Study Start: October 10, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)