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NNC0519-0130 for Obesity

Phase 1

Recruiting

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

Age 18-64 years at the time of signing the informed consent

Male or female of non-childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of first dosing (day 1) until completion of the end of study visit (day 141/162)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new medication, NNC0519-0130, to see if it can help people with excess body weight or type 2 diabetes. Participants will receive two different forms of

Who is the study for?

This trial is for individuals with overweight or obesity. Participants will be involved in the study for about 24 weeks and will receive two different preparations of a new medication, NNC0519-0130, aimed at improving treatment options for excess body weight or type 2 diabetes.

What is being tested?

The study is testing how much of the medicine NNC0519-0130 ends up in the blood when given as two different preparations (NNC0519-0130 B and C). The participants are randomly chosen to receive each preparation to compare their effects on people with excess body weight.

What are the potential side effects?

The summary did not provide specific side effects; however, as with any clinical trial involving new medications, there may be risks of unexpected reactions which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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I cannot become pregnant or get someone pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of first dosing (day 1) until completion of the end of study visit (day 141/162)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of first dosing (day 1) until completion of the end of study visit (day 141/162)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dosing (day 1) until completion of the end of study visit (day 141/162) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)

Secondary study objectives

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state

Number of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2b: NNC0519-0130 C and NNC0519-0130 BExperimental Treatment2 Interventions

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.

Group II: Part 2a: NNC0519-0130 B and NNC0519-0130 CExperimental Treatment2 Interventions

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.

Group III: Part 1b: NNC0519-0130 B and NNC0519-0130 CExperimental Treatment2 Interventions

Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

Group IV: Part 1a: NNC0519-0130 C and NNC0519-0130 BExperimental Treatment2 Interventions

Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

0 / 2Eligibility criteria met