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Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

NCT03308721 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2021-12-23

No results posted yet for this study

Summary

This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body.

Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance.

NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Interventions

DRUG

NNC9204-1177 A 1.0 mg/mL

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.

DRUG

PLACEBO

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2020-01-03
Completion
2020-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03308721 on ClinicalTrials.gov