Clinical trial NCT06064006: 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, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: PART A: Number of treatment emergent adverse events (TEAE)
timeFrame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
measure: PARTS B to E: Number of treatment emergent adverse events (TEAE)
timeFrame: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
Secondary outcomes:
measure: PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
measure: PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
timeFrame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
measure: 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
timeFrame: From pre-dose on V33D1 until end of treatment (V34) up to 9 days
measure: PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax
timeFrame: From pre-dose on V33D1 until end of study visit (V37) up to 24 days
measure: PART B to E: Relative change in body weight
timeFrame: From pre-dose on Day 1 until end of treatment (V34) up to Day 255
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk INvestigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: