A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

Obesity Clinical Trial

Official title:

A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064006
• Other study ID #: NN9490-7613
• Secondary ID: U1111-1289-3282
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: December 12, 2024

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 12, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female

• Aged 18-55 years (both inclusive) at the time of signing informed consent.

• 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:

• 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

• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

• Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening

• Parathyroid hormone (PTH) outside normal range at screening

• Total calcium outside normal range at screening

• Amylase equal to or greater than 2 times upper limit of normal at screening

• Lipase equal to or greater than 2 times upper limit of normal at screening

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• NNC0487-0111
NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
• Placebo (NNC0487-0111)
Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

Locations

Country	Name	City	State
United States	Novo Nordisk INvestigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PART A: Number of treatment emergent adverse events (TEAE)	Number of events	From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Primary	Parts B and C: Number of treatment emergent adverse events (TEAE)	Number of events	From pre-dose on Day 1 until completion of the end of study visit, up to 35 weeks
Secondary	PART A: AUC0-8,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose	h*nmol/L	From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Secondary	PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax	nmol/L	From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Secondary	Parts B and C: The area under the NNC0487-0111 plasma concentration-time curve.	h*nmol/L	From pre-dose on V33 Day1 until V34, up to 9 days
Secondary	Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax	nmol/L	From pre-dose on V33 Day 1 until end of study visit, up to 23 days