DRUG
NNC0487-0111
NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
Status
Completed
Phase
Phase 2
Enrollment
125
Locations
2
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
DRUG
Placebo (NNC0487-0111)
Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Timeline
From registration to results.
First posted
Oct 3, 2023
Study start
Sep 15, 2023
Primary completion
Nov 27, 2024
Study completion
Nov 27, 2024
Results posted
Not reported
Registry updated
Nov 19, 2025
Outcomes
What the study measures.
Primary outcomes
PART A: Number of treatment emergent adverse events (TEAE)
Time frame · From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
Number of events
PARTS B to E: Number of treatment emergent adverse events (TEAE)
Time frame · From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
Number of events
Secondary outcomes
PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame · From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
h\*nmol/L
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
Time frame · From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
nmol/L
PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose
Time frame · From pre-dose on V33D1 until end of treatment (V34) up to 9 days
h\*nmol/L
PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax
Time frame · From pre-dose on V33D1 until end of study visit (V37) up to 24 days
nmol/L
PART B to E: Relative change in body weight
Time frame · From pre-dose on Day 1 until end of treatment (V34) up to Day 255
Percentage (%)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Novo Nordisk INvestigational Site
San Antonio, Texas, United States
Related trials
More studies on Amycretin.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
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AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
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A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
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Recruiting
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AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
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Phase 3
Recruiting
600
2026-07
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
400
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AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
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Related PeptideStat pages
Put the record in context.
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