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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity and Overweight

Treatments: Drug: NNC0165-1875; Drug: Semaglutide; Drug: Placebo (NNC0165-1875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03707990

NN9775-4398

U1111-1212-3615 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

88 participants in 2 patient groups, including a placebo group

NNC0165-1875

Experimental group

Description:

Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2).

Treatment:

Drug: NNC0165-1875

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

Treatment:

Drug: Semaglutide

Drug: Placebo (NNC0165-1875)