A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT03707990
Phase
PHASE1
Status
Completed

Conditions

  • Obesity and Overweight

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • NNC0165-1875 — DRUG
    Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
  • Placebo (NNC0165-1875) — DRUG
    Participants will receive a single dose of s.c. placebo injection.
  • Semaglutide — DRUG
    Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.

Study Details

The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. 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 9 weeks. Participants will have 7 visits to the clinic with the study doctor.

Key Dates

Start date
Oct 15, 2018
Status verified
Sep 2019
Primary completion
Aug 13, 2019
Completion
Aug 13, 2019

Study Design

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

Arms

  • Experimental: NNC0165-1875
    Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2).
  • Placebo Comparator: Placebo
    Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1-36 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteTempeArizona85283-

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Novo Nordisk Investigational Site· Tempe, AZ

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