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Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

This study is currently recruiting participants.
Verified November 2017 by Novo Nordisk A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT03308721
First Posted: October 12, 2017
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body.

Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance.

NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Condition Intervention Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC9204-1177 A 1.0 mg/mL Drug: PLACEBO Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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 Multiple Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Multiple Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1-110 ]
    Count of events


Secondary Outcome Measures:
  • The area under the NNC9204-1177 serum concentration-time curve at steady state [ Time Frame: 0-168 hours ]
    Calculated based on NNC9204-1177 measured in blood.

  • The maximum serum concentration of NNC9204-1177 at steady state [ Time Frame: Day 78-110 ]
    Calculated based on NNC9204-1177 measured in blood.

  • The time to maximum serum concentration of NNC9204-1177 [ Time Frame: Day 78-110 ]
    Calculated based on NNC9204-1177 measured in blood.

  • The terminal half-life of NNC9204-1177 from steady state [ Time Frame: Day 78-110 ]
    Calculated based on NNC9204-1177 measured in blood.


Estimated Enrollment: 72
Actual Study Start Date: October 16, 2017
Estimated Study Completion Date: December 23, 2018
Estimated Primary Completion Date: December 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC9204-1177
Dose trial with a sequential trial design
Drug: NNC9204-1177 A 1.0 mg/mL

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

Dose gradually increased to 6000 μg.

Placebo Comparator: Placebo Drug: PLACEBO
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess 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) risk greater than or equal to 5%
  • Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) 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), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
  • Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and who are not using highly effective contraceptive methods (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or who are pregnant, breast-feeding or intend to become pregnant
  Contacts and Locations
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): NCT03308721


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

Locations
United States, Kansas
Novo Nordisk Investigational Site Recruiting
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Novo Nordisk A/S
  More Information

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03308721     History of Changes
Other Study ID Numbers: NN9277-4328
U1111-1189-1919 ( Other Identifier: World Health Organization (WHO) )
First Submitted: October 9, 2017
First Posted: October 12, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
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://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Overweight
Nutrition Disorders
Overnutrition
Body Weight
Signs and Symptoms