ObesityPhase 1NCT06577766
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
A Phase 1 study testing NNC0638-0355 in people with Obesity and Overweight, run by Novo Nordisk A/S at 4 sites in 2 countries.
Trial summary
The 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 your body, and what your body does to the study medicine. 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?
- NNC0638-0355
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Sep 2024to 11 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- BMI between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy 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.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- HbA1c greater than or equal to 6.5 percentage (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 12 ng/mL (30 nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
ICON Early Phase Services, LLC
Lenexa, Kansas, 66219
ICON-Salt Lake City
Salt Lake City, Utah, 84124
ICON
San Antonio, Texas, 78209
About this study
Official title: A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity
The 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 your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
- Conditions
- Obesity, Overweight
- Being tested
- NNC0638-0355, Placebo (NNC0638-0355)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0638-0355Drug
NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo (NNC0638-0355)Drug
Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.
| Study group | Role | What they receive |
|---|---|---|
| NNC0638-0355 | Experimental | Participants will be randomized to receive NNC0638-0355. 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: NNC0638-0355 |
| 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: Placebo (NNC0638-0355) |
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)
Measured as Number of events
Measured: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
Measured as Number of events
Measured: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Secondary outcomes (4)
Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
Measured in hours*nano mole per litre (h*nmol/L)
Measured: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
Measured in nano mole per litre (nmol/L)
Measured: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
Measured in hour*nano mole per litre (h*nmol/L)
Measured: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration
Measured in nano mole per litre (nmol/L)
Measured: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start3 Sep 2024
- Primary completion11 Oct 2027 (estimated)
- Study completion11 Oct 2027 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 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
- NCT06577766
- Sponsor's protocol ID
- NN9638-7569
- Other IDs
- U1111-1296-8015
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2024
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06577766
- Acronym / sponsor ID
- NN9638-7569
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 11 Oct 2027 (estimated)
- Study completion
- 11 Oct 2027 (estimated)
- First posted
- 29 Aug 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.
The 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 your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0638-0355 | Experimental | Drug: NNC0638-0355Participants will be randomized to receive NNC0638-0355. 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: Placebo (NNC0638-0355)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.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- BMI between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy 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 (7 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- HbA1c greater than or equal to 6.5 percentage (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 |
|---|---|---|
| NNC0638-0355NNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection. | Drug | NNC0638-0355 |
| Placebo (NNC0638-0355)Placebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection. | Drug | Placebo |
Primary outcome
Part A: Number of treatment emergent adverse events (TEAE)
Time frame: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
Measured as Number of events
Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
Time frame: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Measured as Number of events
4 secondary outcomes
Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
Time frame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
Time frame: From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
Time frame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration
Time frame: From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0638-0355 in people with Obesity and Overweight, run by Novo Nordisk A/S at 4 sites in 2 countries.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands. 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 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?
This study is still under way. Results are not available in the source record yet.
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 NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)). 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 30 Sep 2026.