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

NCT07767175 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9060-8607U1111-1334-3077
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Part A: AUC- Area under the NNC0721-8060 plasma concentration time-curve

  From Day 1 to Day 36

• Part A: Cmax- Maximum observed plasma concentration of NNC0721-8060

  From Day 1 to Day 36

• Part B: AUC- Area under the NNC0721-8060 plasma concentration time-curve

  From Day 1 to Day 57

• Part B: Cmax- Maximum observed plasma concentration of NNC0721-8060

  From Day 1 to Day 57

• Part C: AUC- Area under the NNC0721-8060 plasma concentration time-curve

  From Day 1 to Day 113

Study Arms (3)

NNC0721-8060

EXPERIMENTAL

Participants will receive subcutaneous injection of NNC0721-8060.

Drug: NNC0721-8060

Semaglutide

ACTIVE COMPARATOR

Participants will receive subcutaneous injection of semaglutide.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of placebo.

Drug: Placebo

Interventions

NNC0721-8060 DRUG

NNC0721-8060 will be administered subcutaneously.

NNC0721-8060

Semaglutide DRUG

Semaglutide will be administered subcutaneously.

Semaglutide

Placebo DRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON Early Phase Services, LLC

Lenexa, Kansas, 66219, United States

Location

ICON

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)