Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02958085
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: NNC0174-0833; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
• Actual Study Start Date: Nov 4, 2016
• Actual Primary Completion Date: Jan 24, 2018
• Actual Study Completion Date: Jan 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0174-0833	Drug: NNC0174-0833; Doses of NNC0174-0833, dosed either once daily or once weekly
Placebo Comparator: Placebo	Drug: Placebo; Dosed either once daily or once weekly

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events (TEAEs) [From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)]

Secondary Outcome Measures

1. The area under the NNC0174-0833 plasma concentration-time curve [From time 0 to 24 hours at steady state]

   [only applicable for once daily dosing]

2. The area under the NNC0174-0833 plasma concentration-time curve [From time 0 to 168 hours at steady state]

   [only applicable for once weekly dosing]

3. The maximum concentration of NNC0174-0833 in plasma at steady state [Day 1; Day 57]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion Criteria:

• History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention

• History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure

• History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)

• Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and 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) of childbearing potential (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 last dose of investigational medical product

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02958085
• Other Study ID Numbers: NN9838-4021; U1111-1131-7209
• First Posted: Nov 8, 2016
• Last Update Posted: Feb 1, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Obesity; Nutrition Disorders; Overweight

Study Results

No Results Posted as of Feb 1, 2018