Clinical trial NCT03707990: A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity and Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 88
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: Day 1-36
Secondary outcomes:
measure: AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose
timeFrame: 1-36 days
measure: Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose
timeFrame: 1-36 days
measure: AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose
timeFrame: 1-36 days
measure: Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose
timeFrame: 1-36 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: