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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT03574584
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorders
  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0165-1562 — DRUG
    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.
  • Semaglutide — DRUG
    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.
  • Placebo (NNC0165-1562) — DRUG
    Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Study Details

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.

Key Dates

Start date
Jun 18, 2018
Status verified
Jul 2021
Primary completion
Jul 27, 2019
Completion
Jul 27, 2019

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: Week 0-25 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteTempeArizona85283-
Novo Nordisk Investigational SiteLincolnNebraska68502-

Find similar trials in Tempe, AZ

By research site
Novo Nordisk Investigational Site· Tempe, AZNovo Nordisk Investigational Site· Lincoln, NE

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