ObesityPhase 1NCT05369390
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
A Phase 1 study testing NNC0487-0111 A and NNC0487-0111 B in people with Obesity, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0487-0111 A and NNC0487-0111 B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2022to 9 Jan 2024
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A and B:
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening
- 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.
- Part C and D:
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 27.0 to 39.9 kg/m^2 (both inclusive) at screening
- 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
- Part A and B:
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 6.5 % (48 millimoles per mole (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) less than 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
Show all 18Show fewer
- Total calcium outside normal range at screening
- Amylase greater than or equal to 2 times upper limit of normal at screening
- Lipase greater than or equal to 2 times upper limit of normal at screening
- Part C and D:
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 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) less than 20 ng/mL (50 nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Amylase greater than or equal to 2 times upper limit of normal at screening
- Lipase greater than or equal to 2 times upper limit of normal 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: Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases.
This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo).
Read more
Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated.
Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours.
A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose.
- Conditions
- Obesity
- Being tested
- NNC0487-0111 A, NNC0487-0111 B, Placebo B (NNC0487-0111 B), Placebo A (NNC0487-0111 A)
- Keywords
- overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111 ADrug
Participants will receive NNC0487-0111 A tablet once daily.
NNC0487-0111 BDrug
Participants will receive NNC0487-0111 B tablet once daily.
Placebo B (NNC0487-0111 B)Other
Participants will receive placebo matched to NNC0487-0111 B tablet once daily.
Placebo A (NNC0487-0111 A)Other
Participants will receive placebo matched to NNC0487-0111 A tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single ascending dose (SAD) | Experimental | Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. Receives: Drug: NNC0487-0111 A; Other: Placebo A (NNC0487-0111 A) |
| Part B: Multiple ascending dose (MAD) | Experimental | Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. Receives: Drug: NNC0487-0111 A; Other: Placebo A (NNC0487-0111 A) |
| Part C | Experimental | Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12. Receives: Drug: NNC0487-0111 A; Other: Placebo A (NNC0487-0111 A) |
| Part D | Experimental | Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12. Receives: Drug: NNC0487-0111 B; Other: Placebo B (NNC0487-0111 B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE)
Number of events
Measured: Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days
Secondary outcomes (6)
Part A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Hours*Nanomoles per liter (h*nmol/L)
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 22)
Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose
Nanomoles per liter (nmol/L)
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 22)
Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
h*nmol/L
Measured: From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Part B: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
nmol/L
Measured: From pre-dose on Day 10 until Day 22
Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
h*nmol/L
Measured: From pre-dose on Day 84 until Day 85 (24 hours post-dose)
Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
nmol/L
Measured: From pre-dose on Day 84 until completion of the end of study visit (Day 105)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 May 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369390
- Sponsor's protocol ID
- NN9487-4830
- Other IDs
- U1111-1270-0852
- Status last verified
- Jun 2025
- First submitted
- 4 May 2022
- Last updated
- 15 Jun 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
Gasiorek A, Heydorn A, Gabery S, Hjerpsted JB, Kirkeby K, Kruse T, Petersen SB, Toubro S, Vegge A, Key C. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial. Lancet. 2025 Jul 12;406(10499):135-148. doi: 10.1016/S0140-6736(25)01176-6. Epub 2025 Jun 20.
PubMed 40550229
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT05369390
- Acronym / sponsor ID
- NN9487-4830
- Conditions
- Obesity
- Keywords
- overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 11 May 2022 (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.
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases.
This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo).
Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated.
Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours.
A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Single ascending dose (SAD) | Experimental | Drug: NNC0487-0111 A, Other: Placebo A (NNC0487-0111 A)Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part B: Multiple ascending dose (MAD) | Experimental | Drug: NNC0487-0111 A, Other: Placebo A (NNC0487-0111 A)Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part C | Experimental | Drug: NNC0487-0111 A, Other: Placebo A (NNC0487-0111 A)Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12. |
| Part D | Experimental | Drug: NNC0487-0111 B, Other: Placebo B (NNC0487-0111 B)Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening
- 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.
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 27.0 to 39.9 kg/m^2 (both inclusive) at screening
Key exclusion criteria (18 listed)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 6.5 % (48 millimoles per mole (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) less than 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
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 |
|---|---|---|
| NNC0487-0111 AParticipants will receive NNC0487-0111 A tablet once daily. | Drug | Part A: Single ascending dose (SAD), Part B: Multiple ascending dose (MAD), Part C |
| NNC0487-0111 BParticipants will receive NNC0487-0111 B tablet once daily. | Drug | Part D |
| Placebo B (NNC0487-0111 B)Participants will receive placebo matched to NNC0487-0111 B tablet once daily. | Other | Part D |
| Placebo A (NNC0487-0111 A)Participants will receive placebo matched to NNC0487-0111 A tablet once daily. | Other | Part A: Single ascending dose (SAD), Part B: Multiple ascending dose (MAD), Part C |
Primary outcome
Number of treatment emergent adverse events (TEAE)
Time frame: Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days
Number of events
6 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 (Day 22)
Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 22)
Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
Time frame: From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Part B: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
Time frame: From pre-dose on Day 10 until Day 22
Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
Time frame: From pre-dose on Day 84 until Day 85 (24 hours post-dose)
Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
Time frame: From pre-dose on Day 84 until completion of the end of study visit (Day 105)
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 15 Jun 2025.
- Derived from this study: PubMed 40550229Gasiorek A, Heydorn A, Gabery S, Hjerpsted JB, Kirkeby K, Kruse T, Petersen SB, Toubro S, Vegge A, Key C. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial. Lancet. 2025 Jul 12;406(10499):135-148. doi: 10.1016/S0140-6736(25)01176-6. 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0487-0111 A and NNC0487-0111 B in people with Obesity, 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 8 inclusion and 18 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 15 Jun 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of treatment emergent adverse events (TEAE) (time frame: Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days). 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 NCT05369390, 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 15 Jun 2025.