Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC9204-1177 A 1.0 mg/mL
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NNC9204-1177
Placebo
Arm Description
Dose trial with a sequential trial design
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAEs)
Count of events
Secondary Outcome Measures
The area under the NNC9204-1177 serum concentration-time curve at steady state
Calculated based on NNC9204-1177 measured in blood.
The maximum serum concentration of NNC9204-1177 at steady state
Calculated based on NNC9204-1177 measured in blood.
The time to maximum serum concentration of NNC9204-1177
Calculated based on NNC9204-1177 measured in blood.
The terminal half-life of NNC9204-1177 from steady state
Calculated based on NNC9204-1177 measured in blood.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03308721
Brief Title
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Official Title
A Multiple Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Multiple Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC9204-1177
Arm Type
Experimental
Arm Description
Dose trial with a sequential trial design
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NNC9204-1177 A 1.0 mg/mL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count of events
Time Frame
Day 1-110
Secondary Outcome Measure Information:
Title
The area under the NNC9204-1177 serum concentration-time curve at steady state
Description
Calculated based on NNC9204-1177 measured in blood.
Time Frame
0-168 hours
Title
The maximum serum concentration of NNC9204-1177 at steady state
Description
Calculated based on NNC9204-1177 measured in blood.
Time Frame
Day 78-110
Title
The time to maximum serum concentration of NNC9204-1177
Description
Calculated based on NNC9204-1177 measured in blood.
Time Frame
Day 78-110
Title
The terminal half-life of NNC9204-1177 from steady state
Description
Calculated based on NNC9204-1177 measured in blood.
Time Frame
Day 78-110
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Learn more about this trial
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
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