> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-how-nnc0174-1213-works-in-people-with-overweight-9e88dbce-eda4-4f69-820e-de0bad04f8a6 > Record changed: 2026-10-13 # A Study on How NNC0174-1213 Works in People With Overweight or Obesity. NCT06719011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Participants 178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Start date 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Short title** A Study on How NNC0174-1213 Works in People With Overweight or Obesity. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Dates **Completion date** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **First posted** 2024-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Primary completion date** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Start date** 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Size and sites **Actual participants** 178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Participants** 178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Identifiers **Registry ID** NCT06719011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **ClinicalTrials.gov ID** NCT06719011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Double masking **Masking description** Sponsor staff involved in the clinical trial is masked according to company standard procedures. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Outcomes ### Primary outcomes 1. 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) Number of events 2. 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) Number of events ### Secondary outcomes 1. 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) measured in hour\\\*nanomoles per liter (h\\\*nmol/L). 2. 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) measured in nanomoles per liter (nmol/L). 3. 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) measured in h\\\*nmol/L. 4. 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) measured in nmol/L. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Sites - ICON Early Phase Services, LLCSan Antonio, United States - ICON Early Phase Services, LLCSalt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## References ### Other registry identifiers - U1111-1308-5620 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06719011) ## Related records ### Drugs (1) - [Cagrilintide](https://trialight.com/data/asset/cagrilintide-83b81776-3caf-4dea-a1a9-64bd998ac431.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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