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

NCT03095807 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9423-4302U1111-1177-7821
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events (TEAEs)

  Count and % of events

  From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)

Secondary Outcomes (12)

• Area under the NNC9204-1706 plasma concentration-time curve

  Day 1- Day 7

• Area under the NNC9204-1706 plasma concentration-time curve (0-24h)

  Day 1- Day 7

• Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)

  Day 1- Day 7

• Maximal observed concentration of the NNC9204-1706 plasma concentration curve

  Day 1- Day 7

• Time to observed maximum concentration of NNC9204-1706 in plasma

  Day 1- Day 7

Study Arms (2)

NNC9204-1706 A

EXPERIMENTAL

Drug: NNC9204-1706 A

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NNC9204-1706 A DRUG

Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.

NNC9204-1706 A

Placebo DRUG

Administered subcutaneously (s.c., under the skin)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 30, 2017
• Study Start: March 20, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)