A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity

A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0721-8060 in Healthy Adult Participants Living With Overweight or Obesity

The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: Semaglutide; Drug: NNC0721-8060

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Recruiting
      • ICON Early Phase Services, LLC
  • Texas
    • San Antonio, Texas, United States, 78209
      • Not yet recruiting
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female (sex at birth).
• Age 18-55 years (both inclusive) at the time of signing informed consent.
• Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator.
• Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous randomisation in this study.
• History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions.
• Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception.
• Current participation (signed informed consent) in any other interventional clinical study.
• Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening.
• Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0721-8060; Participants will receive subcutaneous injection of NNC0721-8060.	Drug: NNC0721-8060; NNC0721-8060 will be administered subcutaneously.
Active Comparator: Semaglutide; Participants will receive subcutaneous injection of semaglutide.	Drug: Semaglutide; Semaglutide will be administered subcutaneously.
Placebo Comparator: Placebo; Participants will receive subcutaneous injection of placebo.	Drug: Placebo; Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Number of treatment emergent adverse events (TEAE)	Measured as number of events.	From Day 1 to Day 36
Part B: Number of treatment emergent adverse events (TEAE)	Measured as number of events.	From Day 1 to Day 57
Part C: Change from baseline in body weight	Measured as percentage change in body weight.	From Day 1 to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: AUC- Area under the NNC0721-8060 plasma concentration time-curve	Measured as hour nanomoles per litre (h*nmol/L).	From Day 1 to Day 36
Part A: Cmax- Maximum observed plasma concentration of NNC0721-8060	Measured as nanomoles per litre (nmol/L).	From Day 1 to Day 36
Part B: AUC- Area under the NNC0721-8060 plasma concentration time-curve	Measured as h*nmol/L.	From Day 1 to Day 57
Part B: Cmax- Maximum observed plasma concentration of NNC0721-8060	Measured as nmol/L.	From Day 1 to Day 57
Part C: AUC- Area under the NNC0721-8060 plasma concentration time-curve	Measured as h*nmol/L.	From Day 1 to Day 113
Part C: Cmax- Maximum observed plasma concentration of NNC0721-8060	Measured as nmol/L.	From Day 1 to Day 113
Part C: Number of treatment emergent adverse events (TEAE)	Measured as number of events.	From Day 1 to Day 113

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2026
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): September 23, 2027

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; semaglutide
• Other Study ID Numbers: NN9060-8607; U1111-1334-3077 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No