NNC0247-0829 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Summary

This trial tests a new medicine called NNC0247-0829 to help people with overweight or obesity manage their weight. Participants will receive injections of either the medicine or a non-active substance. Researchers will monitor their health and weight through various tests.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)

For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)

Secondary study objectives

For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity

For MD cohorts: Number of injection site reactions

For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatment NNC0247-0829Experimental Treatment1 Intervention

Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment

Group II: PlaceboPlacebo Group1 Intervention

In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NNC0247-0829

2019

Completed Phase 1

~110

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