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A Research Study Investigating NNC0247-0829 for Weight Management 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010786
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: NNC0247-0829 Drug: Placebo (NNC0247-0829) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
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: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: Active treatment NNC0247-0829
Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment
Drug: NNC0247-0829
Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.

Placebo Comparator: Placebo
In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo
Drug: Placebo (NNC0247-0829)
Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.




Primary Outcome Measures :
  1. For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of first dosing (Day 1) until Day 71 ]
    Number of events

  2. For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of first dosing (Day 1) until Day 85 ]
    Number of events


Secondary Outcome Measures :
  1. For SD cohorts: Number of injection site reactions [ Time Frame: From time of first dosing (Day 1) until Day 71 ]
    Number of events

  2. For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies [ Time Frame: From time of first dosing (Day 1) until Day 71 ]
    Number of events

  3. For MD cohorts: Number of injection site reactions [ Time Frame: From time of first dosing (Day 1) until Day 85 ]
    Number of events

  4. For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies [ Time Frame: From time of first dosing (Day 1) until Day 85 ]
    Number of events

  5. For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity [ Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort) ]
    nmol/L*h



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) in SD cohorts and between 27.0 and 39.9 kg/m^2 (both inclusive) in MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

  • Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
  • Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

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): NCT04010786


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Texas
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04010786    
Other Study ID Numbers: NN9215-4424
U1111-1226-5167 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
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

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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
Overweight
Overnutrition
Nutrition Disorders
Body Weight