ObesityPhase 1NCT06719011
A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
A Phase 1 study testing NNC0174-1213 A and Cagrilintide B in people with Obesity and Overweight, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- NNC0174-1213 A and Cagrilintide B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Dec 2024to 20 Jul 2026
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight more than or equal to (>=) 80.0 kilograms (kg) 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
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
- Impaired liver function defined as any of the below:
- Aspartate aminotransferase (AST) more than or equal to (>=) 2 times upper limit of normal at screening
- Alanine aminotransferase (ALT) more than or equal to (>=) 2 times upper limit of normal at screening
Show all 16Show fewer
- Bilirubin more than (>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.
- Glycated haemoglobin (HbA1c) more than or equal to (>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
- Any clinically significant body weight change more than or equal to (>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
- 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 (<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Calcitonin more than or equal to (>=) 50 nanogram per liter (ng/L) at screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON Early Phase Services, LLC
Salt Lake City, Utah, 84124
ICON Early Phase Services, LLC
San Antonio, Texas, 78232
About this study
Official title: A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.
This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
- Conditions
- Obesity, Overweight
- Being tested
- NNC0174-1213 A, Cagrilintide B, Placebo A (NNC0174 1213 A)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174-1213 ADrug
Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection.
Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Cagrilintide BDrug
Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection.
Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Placebo A (NNC0174 1213 A)Drug
Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection.
Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Part A: NNC0174-1213 (SD1-SD5) | Experimental | Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
| Part A: Cagrilintide (SDA and SDB) | Experimental | Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2.
Cagrilintide SDB will be administered in cohort 3 and 4. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
| Part A: Placebo | Experimental | Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
| Part B: NNC0174-1213 (MD1-MD5) | Experimental | Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
| Part B: Cagrilintide (MDA) | Experimental | Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
| Part B: Placebo | Experimental | Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5. Receives: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A) |
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) reported by participants exposed to NNC0174 1213
Number of events
Measured: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
Part B: Number of treatment emergent adverse events (TEAE)
Number of events
Measured: From first administration (Day 1) to completion of the end of study visit (Day 67)
Secondary outcomes (4)
Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve
measured in hour*nanomoles per liter (h*nmol/L).
Measured: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part A: Cmax; maximum observed NNC0174 1213 plasma concentration
measured in nanomoles per liter (nmol/L).
Measured: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve
measured in h*nmol/L.
Measured: From first administration (Day 1) to completion of the end of study visit (Day 67)
Part B: Cmax; maximum observed NNC0174 1213 plasma concentration
measured in nmol/L.
Measured: From first administration (Day 1) to completion of the end of study visit (Day 67)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start3 Dec 2024
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 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
- NCT06719011
- Sponsor's protocol ID
- NN9839-8082
- Other IDs
- U1111-1308-5620
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2024
- Last updated
- 25 Aug 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.
- ClinicalTrials.gov ID
- NCT06719011
- Acronym / sponsor ID
- NN9839-8082
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 5 Dec 2024 (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.
This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: NNC0174-1213 (SD1-SD5) | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5. |
| Part A: Cagrilintide (SDA and SDB) | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4. |
| Part A: Placebo | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5. |
| Part B: NNC0174-1213 (MD1-MD5) | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5. |
| Part B: Cagrilintide (MDA) | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5. |
| Part B: Placebo | Experimental | Drug: NNC0174-1213 A, Drug: Cagrilintide B, Drug: Placebo A (NNC0174 1213 A)Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Body weight more than or equal to (>=) 80.0 kilograms (kg) 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.
Key exclusion criteria (16 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
- Impaired liver function defined as any of the below:
- Aspartate aminotransferase (AST) more than or equal to (>=) 2 times upper limit of normal 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 |
|---|---|---|
| NNC0174-1213 AParticipants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. | Drug | Part A: Cagrilintide (SDA and SDB), Part A: NNC0174-1213 (SD1-SD5), Part A: Placebo, Part B: Cagrilintide (MDA), Part B: NNC0174-1213 (MD1-MD5), Part B: Placebo |
| Cagrilintide BParticipants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. | Drug | Part A: Cagrilintide (SDA and SDB), Part A: NNC0174-1213 (SD1-SD5), Part A: Placebo, Part B: Cagrilintide (MDA), Part B: NNC0174-1213 (MD1-MD5), Part B: Placebo |
| Placebo A (NNC0174 1213 A)Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. | Drug | Part A: Cagrilintide (SDA and SDB), Part A: NNC0174-1213 (SD1-SD5), Part A: Placebo, Part B: Cagrilintide (MDA), Part B: NNC0174-1213 (MD1-MD5), Part B: Placebo |
Primary outcome
Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
Time frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
Number of events
Part B: Number of treatment emergent adverse events (TEAE)
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Number of events
4 secondary outcomes
Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve
Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part A: Cmax; maximum observed NNC0174 1213 plasma concentration
Time frame: From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Part B: Cmax; maximum observed NNC0174 1213 plasma concentration
Time frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
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 25 Aug 2026.
- 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 1 study testing NNC0174-1213 A and Cagrilintide B 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 5 inclusion and 16 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 25 Aug 2026. 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?
Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 (time frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)). 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?
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 25 Aug 2026.