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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services, LLC
    • San Antonio, Texas, United States, 78209
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0487-0111; 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)	Drug: NNC0487-0111; NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.; Drug: Placebo (NNC0487-0111); Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo Comparator: Placebo; 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).	Drug: NNC0487-0111; NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.; Drug: Placebo (NNC0487-0111); Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Day 25
PARTS B to E: Number of treatment emergent adverse events (TEAE)	Number of events	From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
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 Day 25
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	h*nmol/L	From pre-dose on V33D1 until end of treatment (V34) up to 9 days
PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax	nmol/L	From pre-dose on V33D1 until end of study visit (V37) up to 24 days
PART B to E: Relative change in body weight	Percentage (%)	From pre-dose on Day 1 until end of treatment (V34) up to Day 255

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Publications and helpful links

General Publications

• Dahl K, Toubro S, Dey S, Duque do Vale R, Flint A, Gasiorek A, Heydorn A, Jastreboff AM, Key C, Petersen SB, Vegge A, Adelborg K. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. 2025 Jul 12;406(10499):149-162. doi: 10.1016/S0140-6736(25)01185-7. Epub 2025 Jun 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9490-7613; U1111-1289-3282 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No