search
Back to results

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

Primary Purpose

Obesity, Overweight

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0487-0111
Placebo (NNC0487-0111)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0487-0111

Placebo

Arm Description

Participants will be randomized to receive NNC0487-0111. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD) Part B and C: Multiple ascending dose (MAD)

Participants will be randomized to receive Placebo. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD). Part B and C: Multiple ascending dose (MAD).

Outcomes

Primary Outcome Measures

PART A: Number of treatment emergent adverse events (TEAE)
Number of events
Parts B and C: Number of treatment emergent adverse events (TEAE)
Number of events

Secondary Outcome Measures

PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
h*nmol/L
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
nmol/L
Parts B and C: The area under the NNC0487-0111 plasma concentration-time curve.
h*nmol/L
Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax
nmol/L

Full Information

First Posted
September 11, 2023
Last Updated
September 28, 2023
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT06064006
Brief Title
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NNC0487-0111
Arm Type
Experimental
Arm Description
Participants will be randomized to receive NNC0487-0111. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD) Part B and C: Multiple ascending dose (MAD)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive Placebo. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD). Part B and C: Multiple ascending dose (MAD).
Intervention Type
Drug
Intervention Name(s)
NNC0487-0111
Intervention Description
NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0487-0111)
Intervention Description
Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Primary Outcome Measure Information:
Title
PART A: Number of treatment emergent adverse events (TEAE)
Description
Number of events
Time Frame
From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Title
Parts B and C: Number of treatment emergent adverse events (TEAE)
Description
Number of events
Time Frame
From pre-dose on Day 1 until completion of the end of study visit, up to 35 weeks
Secondary Outcome Measure Information:
Title
PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Description
h*nmol/L
Time Frame
From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Title
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
Description
nmol/L
Time Frame
From pre-dose on Day 1 until completion of the end of study visit, up to 24 days
Title
Parts B and C: The area under the NNC0487-0111 plasma concentration-time curve.
Description
h*nmol/L
Time Frame
From pre-dose on V33 Day1 until V34, up to 9 days
Title
Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax
Description
nmol/L
Time Frame
From pre-dose on V33 Day 1 until end of study visit, up to 23 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs