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

NCT06064006 | Completed Phase 2 FDA Drug

• 2 other identifiers: NN9490-7613U1111-1289-3282
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

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

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

  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

  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

  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

  From pre-dose on V33D1 until end of study visit (V37) up to 24 days

• PART B to E: Relative change in body weight

  From pre-dose on Day 1 until end of treatment (V34) up to Day 255

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

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; Drug: Placebo (NNC0487-0111)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo (NNC0487-0111)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

NNC0487-0111; Placebo

Placebo (NNC0487-0111) DRUG

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

NNC0487-0111; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

Novo Nordisk INvestigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 40550231 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 3, 2023
• Study Start: September 15, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (2)