NNC0487-0111 for Obesity

Recruiting at2 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novo Nordisk A/S

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called NNC0487-0111, given as an injection under the skin, to see if it is safe and how it works in the body.

Research Team

Clinical Transparency dept. 2834

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for men and women aged 18-55 with a BMI between 27.0 and 39.9, indicating overweight due to excess fat as assessed by the study's doctor. Participants must pass health checks including vital signs, heart tests, and lab tests. Those with conditions affecting safety or protocol adherence, high blood sugar levels (HbA1c ≥6.5%), very low vitamin D, abnormal parathyroid hormone or calcium levels, or significantly elevated amylase/lipase/calcitonin are excluded.

Inclusion Criteria

I am either male or female.

Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria

Calcitonin equal to or greater than 50 ng/L at screening

Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening

Treatment Details

Interventions

• NNC0487-0111 (Other)

Trial Overview The trial is testing NNC0487-0111, a new drug given as an under-the-skin injection to see if it's safe and how it works in people with obesity compared to a placebo (a substance with no active drug).

Participant Groups

Group I: NNC0487-0111 Experimental Treatment 2 Interventions

Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)

Group II: Placebo Placebo Group 2 Interventions

Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen