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

Phase 1

Completed

• Conditions: Obesity and Overweight
• Interventions: Drug: NNC0165-1875; Drug: Placebo (NNC0165-1875); Drug: Semaglutide

• Registration Number: NCT03707990
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study Start: 2018-10-15
• Study First Posted: 2018-10-16
• Primary Completion: 2019-08-13
• Study Completion: 2019-08-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

• Males, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
• Body weight greater than or equal to 70 kg

Exclusion Criteria

• Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0165-1875	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).
NNC0165-1875	Semaglutide	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	Placebo (NNC0165-1875)	Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).
Placebo	Semaglutide	Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	Day 1-36	Count of adverse events.

Secondary Outcome Measures

Name	Time	Method
AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose	1-36 days	Calculated based on plasma semaglutide measured (nmol\*h/L) in blood.
Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose	1-36 days	Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood.
AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose	1-36 days	Calculated based on plasma NNC0165-1875 measured (nmol\*h/L) in blood.
Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose	1-36 days	Calculated based on plasma semaglutide measured (nmol/L) in blood.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Tempe, Arizona, United States