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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Drug: NNC0165-1875; Drug: Semaglutide; Drug: Placebo (NNC0165-1875)

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.; Drug: Semaglutide; Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.
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).	Drug: Semaglutide; Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.; Drug: Placebo (NNC0165-1875); Participants will receive a single dose of s.c. placebo injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Count of adverse events.	Day 1-36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞,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
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
AUC0-∞,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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ACTUAL): August 13, 2019
• Study Completion (ACTUAL): August 13, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: NN9775-4398; U1111-1212-3615 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No