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NNC0113-5840 for Obesity

Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
Disqualifiers: Hypersensitivity, HbA1c ≥ 6.5%, others

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Inclusion Criteria

I am male or female.
I am between 18 and 55 years old.
3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of NNC0113-5840 or placebo subcutaneously

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0113-5840

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 6 NNC0113-5840Experimental Treatment1 Intervention
Group II: Cohort 5 NNC0113-5840Experimental Treatment1 Intervention
Group III: Cohort 4 NNC0113-5840Experimental Treatment1 Intervention
Group IV: Cohort 3 NNC0113-5840Experimental Treatment1 Intervention
Group V: Cohort 2 NNC0113-5840Experimental Treatment1 Intervention
Group VI: Cohort 1 NNC0113-5840Experimental Treatment1 Intervention
Group VII: Placebo matching NNC0113-5840Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

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