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

Phase 2

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)

• Registration Number: NCT06064006
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study Start: 2023-09-15
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-03
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0487-0111	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)
NNC0487-0111	Placebo (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)
Placebo	NNC0487-0111	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).
Placebo	Placebo (NNC0487-0111)	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).

Primary Outcome Measures

Name	Time	Method
PART A: Number of treatment emergent adverse events (TEAE)	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)	From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270	Number of events

Secondary Outcome Measures

Name	Time	Method
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	h\*nmol/L
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	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	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	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	From pre-dose on Day 1 until end of treatment (V34) up to Day 255	Percentage (%)

Trial Locations

Locations (2)

ICON Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States

Novo Nordisk INvestigational Site; 🇺🇸 San Antonio, Texas, United States