Clinical trial NCT06719011: A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
Official title: A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male 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: 2024-12-05
Enrollment: 177
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This 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 human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.


Eligibility criteria: Inclusion Criteria:

* Male.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening.
* 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:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
* Impaired liver function defined as any of the below:
* Aspartate aminotransferase (AST) more than or equal to (\>=) 2 times upper limit of normal at screening
* Alanine aminotransferase (ALT) more than or equal to (\>=) 2 times upper limit of normal at screening
* Bilirubin more than (\>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at screening.
* Glycated haemoglobin (HbA1c) more than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
* Any clinically significant body weight change more than or equal to (\>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .
* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
* Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening
* Parathyroid hormone (PTH) outside normal range at screening
* Total calcium outside normal range at screening
* Calcitonin more than or equal to (\>=) 50 nanogram per liter (ng/L) at screening

Primary outcomes:
measure: Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
timeFrame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
measure: Part B: Number of treatment emergent adverse events (TEAE)
timeFrame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Secondary outcomes:
measure: Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve
timeFrame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
measure: Part A: Cmax; maximum observed NNC0174 1213 plasma concentration
timeFrame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
measure: Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve
timeFrame: From first administration (Day 1) to completion of the end of study visit (Day 67)
measure: Part B: Cmax; maximum observed NNC0174 1213 plasma concentration
timeFrame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC
state: Texas
city: Salt Lake City
country: United States
facility: ICON Early Phase Services, LLC
state: Utah
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: