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ObesityPhase 2NCT06064006

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

A Phase 2 study testing NNC0487-0111 in people with Obesity and Overweight, run by Novo Nordisk A/S at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity, Overweight
What is being tested?
NNC0487-0111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
2 sitesUnited States
Study dates
15 Sep 2023to 27 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female
  • Aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • 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.

Who cannot join

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  • Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening
  • Parathyroid hormone (PTH) outside normal range at screening
  • Total calcium outside normal range at screening
Show all 9Show fewer
  • Amylase equal to or greater than 2 times upper limit of normal at screening
  • Lipase equal to or greater than 2 times upper limit of normal at screening
  • Calcitonin equal to or greater than 50 ng/L at screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • ICON Early Phase Services, LLC

    San Antonio, Texas, 78209

  • Novo Nordisk INvestigational Site

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin

Conditions
Obesity, Overweight
Being tested
NNC0487-0111, Placebo (NNC0487-0111)
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0487-0111Drug

    NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

  • Placebo (NNC0487-0111)Drug

    Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

Study groups in NCT06064006
Study groupRoleWhat they receive
NNC0487-0111ExperimentalParticipants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)
Receives: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)
PlaceboPlacebo comparatorParticipants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).
Receives: Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of events

    Measured: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

  2. PARTS B to E: Number of treatment emergent adverse events (TEAE)

    Number of events

    Measured: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270

Secondary outcomes (5)

  1. PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

    h*nmol/L

    Measured: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

  2. PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax

    nmol/L

    Measured: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

  3. PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose

    h*nmol/L

    Measured: From pre-dose on V33D1 until end of treatment (V34) up to 9 days

  4. PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax

    nmol/L

    Measured: From pre-dose on V33D1 until end of study visit (V37) up to 24 days

  5. PART B to E: Relative change in body weight

    Percentage (%)

    Measured: From pre-dose on Day 1 until end of treatment (V34) up to Day 255

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start15 Sep 2023
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064006
Sponsor's protocol ID
NN9490-7613
Other IDs
U1111-1289-3282
Status last verified
Nov 2025
First submitted
11 Sep 2023
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Publications

  • Dahl K, Toubro S, Dey S, Duque do Vale R, Flint A, Gasiorek A, Heydorn A, Jastreboff AM, Key C, Petersen SB, Vegge A, Adelborg K. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. 2025 Jul 12;406(10499):149-162. doi: 10.1016/S0140-6736(25)01185-7. Epub 2025 Jun 20.

    PubMed 40550231

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0487-0111 in people with Obesity and Overweight, run by Novo Nordisk A/S at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART A: Number of treatment emergent adverse events (TEAE) (time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06064006, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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