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

Overweight or Obesity Clinical Trial

Official title:

An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574584
• Other study ID #: NN9747-4261
• Secondary ID: U1111-1191-5147
• Status: Completed
• Phase: Phase 1
• Start date: June 18, 2018
• Est. completion date: July 27, 2019

Study information

• Verified date: July 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 27, 2019
• Est. primary completion date: July 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorders
• Nutrition Disorders
• Obesity
• Overweight
• Overweight or Obesity

Intervention

Drug:
• NNC0165-1562
Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
• Semaglutide
Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
• Placebo (NNC0165-1562)
Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Lincoln	Nebraska
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.	Week 0-25
Secondary	AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state	Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.	Week 19 (day 134) to week 20 (day 141)
Secondary	AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state	Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.	Week 19 (day 134) to week 20 (day 141)