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Trial record 1 of 2 for:    NN9423
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Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661879
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
The study is testing a new medicine for weight control in people with overweight or obesity. The aim of the study is to find out how safe the study medicine is and how it works in the body. Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy medicine) - which treatment participants get is decided by chance. NNC9204-1706 is a new medicine which cannot be prescribed by doctors. Participants will get an injection under the skin of participants' stomach each morning for 10 weeks. A medical tool called NovoPen®4 will be used for the injection. Participants must change the part of the pen including the medicine (the cartridge) each day. The study will last for about 16 weeks. Participants will have at least 17 clinic visits and 10 phone calls with the study doctor. At certain times during the study, participants will have blood drawn and 3 different kinds of heart tests (electrocardiograms). Study doctor will ask participants to answer mental health surveys.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC9204-1706 Drug: Placebo (NNC9204-1706) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Five (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjects
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: A Randomised, Double-blinded, Multiple-dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC9204-1706 in Subjects Being Overweight or With Obesity
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : October 9, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC9204-1706
Participants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.
 Drug: NNC9204-1706
Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
Placebo Comparator: Placebo (NNC9204-1706)
Participants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.
 Drug: Placebo (NNC9204-1706)
Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Days 1-84 ]
    Count of adverse events.


Secondary Outcome Measures :
  1. Change in time-profile (msec) in individual corrected QT interval (ΔQTcI) [ Time Frame: Day 1, Day 84 ]
    Measured in msec.

  2. AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state [ Time Frame: Days 1-84 ]
    Measured in h*nmol/L.

  3. Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state [ Time Frame: Days 1-84 ]
    Measured in nmol/L.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 18-55 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 adipose tissue, as judged by the investigator.

Exclusion Criteria:

  • Female subject who is of childbearing potential (pre-menopausal and not surgically sterilised) and is sexually active with male partner(s) who are not surgically sterilised (vasectomy) or who is not using highly effective contraceptive methods (Pearl Index less than 1%) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
  • Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and 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 nonpregnant female partner(s) (Pearl Index less than 1%), and/or intend to donate sperm in the period from screening until 90 days following administration of the investigational medical product.
  • Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661879


Locations
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United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03661879    
Other Study ID Numbers: NN9423-4393
U1111-1208-7677 ( Other Identifier: World Health Organization (WHO) )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Nutrition Disorders
Overweight
Overnutrition
Body Weight