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

Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC9204-1706 A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Novo Nordisk INvestigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Administered subcutaneously (s.c., under the skin)
EXPERIMENTAL: NNC9204-1706 A	Drug: NNC9204-1706 A; Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the NNC9204-1706 plasma concentration-time curve	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Maximal observed concentration of the NNC9204-1706 plasma concentration curve	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Time to observed maximum concentration of NNC9204-1706 in plasma	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Terminal half-life of NNC9204-1706	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Mean residence time of NNC9204-1706	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
The apparent total plasma clearance of NNC9204-1706	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
The apparent volume of distribution of NNC9204-1706	Calculated based on NNC9204-1706 measured in blood.	Day 1- Day 7
Changes in Body weight	Measured in kg and/or %	Day 1, Days 10-13
Number of injection-site reactions	Count of reactions	From the time of dosing (Day 1) to the follow-up visit (Days 10-13)
Number of hypoglycaemic episodes	Count of episodes	from time of dosing (Day 1) to the follow-up visit (Days 10-13)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2017
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Body Weight; Obesity; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9423-4302; U1111-1177-7821 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No