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

NCT07767175
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
142
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Lead sponsor
Novo Nordisk A/S
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Start date
2026-08-12
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Number of sites
2
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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.
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Short title
A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity
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Official title
A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0721-8060 in Healthy Adult Participants Living With Overweight or Obesity
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-09-23
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First posted
2026-08-17
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Registry last updated
2026-09-04
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Primary completion date
2027-09-23
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Start date
2026-08-12
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Participants
142
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Participant count basis
Estimated
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Planned participants
142
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Protocol amendments
0
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07767175
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ClinicalTrials.gov ID
NCT07767175
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
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
clinicaltrials.gov

  1. Part A: Number of treatment emergent adverse events (TEAE)

    Timeframe: From Day 1 to Day 36

    Measured as number of events.

  2. Part B: Number of treatment emergent adverse events (TEAE)

    Timeframe: From Day 1 to Day 57

    Measured as number of events.

  3. Part C: Change from baseline in body weight

    Timeframe: From Day 1 to Day 85

    Measured as percentage change in body weight.

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

    Timeframe: From Day 1 to Day 36

    Measured as hour nanomoles per litre (h\*nmol/L).

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

    Timeframe: From Day 1 to Day 36

    Measured as nanomoles per litre (nmol/L).

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

    Timeframe: From Day 1 to Day 57

    Measured as h\*nmol/L.

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

    Timeframe: From Day 1 to Day 57

    Measured as nmol/L.

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

    Timeframe: From Day 1 to Day 113

    Measured as h\*nmol/L.

  6. Part C: Cmax- Maximum observed plasma concentration of NNC0721-8060

    Timeframe: From Day 1 to Day 113

    Measured as nmol/L.

  7. Part C: Number of treatment emergent adverse events (TEAE)

    Timeframe: From Day 1 to Day 113

    Measured as number of events.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • ICON Early Phase Services, LLCLenexa, United StatesRecruiting
  • ICONSan Antonio, United StatesNot yet recruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1334-3077
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)