Obesity and OverweightPhase 1NCT03707990
A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese
A Phase 1 study testing NNC0165-1875 and Semaglutide in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- NNC0165-1875 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 13 Aug 2019
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (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
- Body weight greater than or equal to 70 kg
Who cannot join
- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Tempe, Arizona, 85283
About this study
Official title: A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity
The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 9 weeks. Participants will have 7 visits to the clinic with the study doctor.
- Conditions
- Obesity and Overweight
- Being tested
- NNC0165-1875, Placebo (NNC0165-1875), Semaglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0165-1875Drug
Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
Placebo (NNC0165-1875)Drug
Participants will receive a single dose of s.c. placebo injection.
SemaglutideDrug
Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.
| Study group | Role | What they receive |
|---|---|---|
| NNC0165-1875 | Experimental | Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2). Receives: Drug: NNC0165-1875; Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2). Receives: Drug: Placebo (NNC0165-1875); Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count of adverse events.
Measured: Day 1-36
Secondary outcomes (4)
AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose
Calculated based on plasma NNC0165-1875 measured (nmol*h/L) in blood.
Measured: 1-36 days
Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose
Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood.
Measured: 1-36 days
AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose
Calculated based on plasma semaglutide measured (nmol*h/L) in blood.
Measured: 1-36 days
Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose
Calculated based on plasma semaglutide measured (nmol/L) in blood.
Measured: 1-36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start15 Oct 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Model description
- In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707990
- Sponsor's protocol ID
- NN9775-4398
- Other IDs
- U1111-1212-3615
- Status last verified
- Sep 2019
- First submitted
- 12 Oct 2018
- Last updated
- 6 Sep 2019
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03707990
- Acronym / sponsor ID
- NN9775-4398
- Conditions
- Obesity and Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 16 Oct 2018 (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 looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 9 weeks. Participants will have 7 visits to the clinic with the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.
| Arm | Type | Receives |
|---|---|---|
| NNC0165-1875 | Experimental | Drug: NNC0165-1875, Drug: SemaglutideParticipants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2). |
| Placebo | Placebo comparator | Drug: Placebo (NNC0165-1875), Drug: SemaglutideParticipants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2). |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (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
- Body weight greater than or equal to 70 kg
Key exclusion criteria (1 listed)
- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
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 |
|---|---|---|
| NNC0165-1875Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg. | Drug | NNC0165-1875 |
| Placebo (NNC0165-1875)Participants will receive a single dose of s.c. placebo injection. | Drug | Placebo |
| SemaglutideParticipants will receive a single dose of s.c. semaglutide 0.25 mg injection. | Drug | NNC0165-1875, Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: Day 1-36
Count of adverse events.
4 secondary outcomes
AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose
Time frame: 1-36 days
Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose
Time frame: 1-36 days
AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose
Time frame: 1-36 days
Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose
Time frame: 1-36 days
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 6 Sep 2019.
- 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 Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0165-1875 and Semaglutide in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site 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 3 inclusion and 1 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 (TEAEs) (time frame: Day 1-36). 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 6 Sep 2019.