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

NCT04010786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Placebo (NNC0247-0829)

Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2022-06-11
Completion
2022-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010786 on ClinicalTrials.gov