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.
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
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 group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants 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) |
| Placebo | Placebo comparator | Participants 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.
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
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)
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
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
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
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
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.
- First posted3 Oct 2023
- Study start15 Sep 2023
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06064006
- Acronym / sponsor ID
- NN9490-7613
- Conditions
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111, Drug: Placebo (NNC0487-0111)Participants 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) |
| Placebo | Placebo comparator | Drug: NNC0487-0111, Drug: Placebo (NNC0487-0111)Participants 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. | Drug | NNC0487-0111, Placebo |
| Placebo (NNC0487-0111)Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. | Drug | NNC0487-0111, Placebo |
Primary outcome
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
Number of events
PARTS B to E: Number of treatment emergent adverse events (TEAE)
Time frame: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
Number of events
5 secondary outcomes
PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
Time frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
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
Time frame: From pre-dose on V33D1 until end of treatment (V34) up to 9 days
PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax
Time frame: From pre-dose on V33D1 until end of study visit (V37) up to 24 days
PART B to E: Relative change in body weight
Time frame: From pre-dose on Day 1 until end of treatment (V34) up to Day 255
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 40550231Dahl 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.