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A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

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: NCT03574584
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorders Overweight or Obesity Drug: NNC0165-1562 Drug: Semaglutide Drug: Placebo (NNC0165-1562) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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:

  1. Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort)
  2. Semaglutide and placebo once weekly (3 subjects per cohort)
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: An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : July 27, 2019
Actual Study Completion Date : July 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC0165-1562 + Semaglutide
Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
 Drug: NNC0165-1562
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.

Drug: Semaglutide
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.

Drug: Placebo (NNC0165-1562)
Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
Experimental: Placebo (NNC0165-1562) + Semaglutide
Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
 Drug: NNC0165-1562
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.

Drug: Semaglutide
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.

Drug: Placebo (NNC0165-1562)
Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Week 0-25 ]
    Count of adverse events.


Secondary Outcome Measures :
  1. AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state [ Time Frame: Week 19 (day 134) to week 20 (day 141) ]
    Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.

  2. AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state [ Time Frame: Week 19 (day 134) to week 20 (day 141) ]
    Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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): NCT03574584


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Tempe, Arizona, United States, 85283
United States, Nebraska
Novo Nordisk Investigational Site
Lincoln, Nebraska, United States, 68502
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: NCT03574584    
Other Study ID Numbers: NN9747-4261
U1111-1191-5147 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021
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