Clinical trial NCT06577766: A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
Official title: A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 88
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 study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.


Eligibility criteria: Key inclusion criteria

* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered to be generally healthy 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.

Key exclusion criteria

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

  1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
  2. Parathyroid hormone (PTH) outside normal range at screening
  3. Total calcium outside normal range at screening

Primary outcomes:
measure: Part A: Number of treatment emergent adverse events (TEAE)
timeFrame: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
measure: Part B,C,D : Number of treatment emergent adverse events (TEAE)
timeFrame: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Secondary outcomes:
measure: Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
timeFrame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
measure: Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
timeFrame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
measure: Part A: t½; terminal half-life of NNC0638-0355
timeFrame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
measure: Part B,C,D: AUC; area under the NNC0638-0355 plasma concentration-time curve
timeFrame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
measure: Part B,C,D: Cmax; maximum observed NNC0638-0355 plasma concentration
timeFrame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON
state: Texas
city: San Antonio
country: United States
facility: ICON
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: