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

Obesity and Overweight Clinical Trial

Official title:

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707990
• Other study ID #: NN9775-4398
• Secondary ID: U1111-1212-3615
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: August 13, 2019

Study information

• Verified date: September 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Obesity and Overweight
• Overweight

Intervention

Drug:
• NNC0165-1875
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)
Participants will receive a single dose of s.c. placebo injection.
• Semaglutide
Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Count of adverse events.	Day 1-36
Secondary	AUC0-8,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose	Calculated based on plasma NNC0165-1875 measured (nmol*h/L) in blood.	1-36 days
Secondary	Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose	Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood.	1-36 days
Secondary	AUC0-8,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose	Calculated based on plasma semaglutide measured (nmol*h/L) in blood.	1-36 days
Secondary	Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose	Calculated based on plasma semaglutide measured (nmol/L) in blood.	1-36 days