A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight or Obesity; Metabolism and Nutrition Disorders

Treatments: Drug: Placebo (NNC0165-1562); Drug: Semaglutide; Drug: NNC0165-1562

Study type: Interventional

Funder types: Industry

Identifiers

NCT03574584

NN9747-4261

U1111-1191-5147 (Other Identifier)

Details and patient eligibility

About

The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. 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 7 months. Participants will have 27 visits to the clinic.

Enrollment: 37 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

• Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
• Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s), who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

37 participants in 2 patient groups

NNC0165-1562 + Semaglutide

Experimental group

Description:

Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.

Treatment:

Drug: Semaglutide

Drug: Placebo (NNC0165-1562)

Drug: NNC0165-1562

Placebo (NNC0165-1562) + Semaglutide

Experimental group

Description:

Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.

Treatment:

Drug: Semaglutide

Drug: Placebo (NNC0165-1562)

Drug: NNC0165-1562