A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

Obesity Clinical Trial

Official title:

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010786
• Other study ID #: NN9215-4424
• Secondary ID: U1111-1226-5167
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2019
• Est. completion date: June 21, 2022

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 21, 2022
• Est. primary completion date: June 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.

• Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

• Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.

• Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

• Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• NNC0247-0829
Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.
• Placebo (NNC0247-0829)
Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

Locations

Country	Name	City	State
United States	ICON Early Phase Services, LLC	San Antonio	Texas

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	For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)	Number of events	From time of first dosing (Day 1) until Day 71
Primary	For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)	Number of events	From time of first dosing (Day 1) until Day 85
Secondary	For SD cohorts: Number of injection site reactions	Number of events	From time of first dosing (Day 1) until Day 71
Secondary	For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies	Number of events	From time of first dosing (Day 1) until Day 71
Secondary	For MD cohorts: Number of injection site reactions	Number of events	From time of first dosing (Day 1) until Day 85
Secondary	For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies	Number of events	From time of first dosing (Day 1) until Day 85
Secondary	For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity	nmol/L*h	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)