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

NCT03574584 · Completed

Last updated 2026-05-28

This study tests the safety of two medications, NNC0165-1562 and semaglutide, in adults who are overweight or obese by tracking side effects that occur during treatment.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 37 people

Who can join Ages 19–55 · all sexes

Timeline Started 2018-06 · est. completion 2019-07

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT03574584 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Number of treatment emergent adverse events (TEAEs)
Sponsor	Novo Nordisk A/S
Conditions studied	Metabolism and Nutrition Disorders, Overweight or Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03574584 ↗