Back to resultsA Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Primary Purpose
Metabolism and Nutrition Disorders, Overweight or Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0165-1562
Semaglutide
Placebo (NNC0165-1562)
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorders
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
Exclusion Criteria:
- 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 are not using highly effective contraceptive methods (Pearl Index less than 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 are pregnant, breast-feeding or intend to become pregnant.
- Male subjects who are not 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 less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NNC0165-1562 + Semaglutide
Placebo (NNC0165-1562) + Semaglutide
Arm Description
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAEs)
Count of adverse events.
Secondary Outcome Measures
AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state
Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state
Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03574584
Brief Title
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Official Title
An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
July 27, 2019 (Actual)
Study Completion Date
July 27, 2019 (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
The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 7 months. Participants will have 27 visits to the clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorders, Overweight or Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Three (3) cohorts are planned. In each cohort subjects will be assigned to trial product. Subjects will be randomised in a 3:1 manner within cohorts to receive either:
Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort)
Semaglutide and placebo once weekly (3 subjects per cohort)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0165-1562 + Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
Arm Title
Placebo (NNC0165-1562) + Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
Intervention Type
Drug
Intervention Name(s)
NNC0165-1562
Intervention Description
Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0165-1562)
Intervention Description
Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count of adverse events.
Time Frame
Week 0-25
Secondary Outcome Measure Information:
Title
AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state
Description
Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
Time Frame
Week 19 (day 134) to week 20 (day 141)
Title
AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state
Description
Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
Time Frame
Week 19 (day 134) to week 20 (day 141)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
Exclusion Criteria:
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 are not using highly effective contraceptive methods (Pearl Index less than 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 are pregnant, breast-feeding or intend to become pregnant.
Male subjects who are not 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 less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
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
IPD Sharing URL
http://novonordisk-trials.com/sharing-results
Learn more about this trial
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
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