ObesityPhase 2NCT04969939
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
A Phase 2 study testing Semaglutide 2.4 mg and NNC0165-1875 2.0 mg and Semaglutide 2.4 mg and NNC0165-1875 1.0 mg in people with Obesity, run by Novo Nordisk A/S at 25 sites in United States.
Trial summary
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide 2.4 mg and NNC0165-1875 2.0 mg and Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 25 sitesUnited States
- Study dates
- 15 Jul 2021to 30 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.
Who cannot join
- HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
AMC Community Endocrinology
Albany, New York, 12206
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, 78749
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
Medical Uni of SC Charleston
Charleston, South Carolina, 29425
Profil Institute For Clinical Research Inc
Chula Vista, California, 91911
Soltero Cardiovascular Research Center
Dallas, Texas, 75226
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
East West Med Res Inst
Honolulu, Hawaii, 96814
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
Velocity Clin Res Los Angeles
Los Angeles, California, 90017
L-MARC Research Center
Louisville, Kentucky, 40213
NYC Research, Inc.
New York, New York, 10016
Health Res of Hampton Roads
Newport News, Virginia, 23606
Coastal Carolina Res Ctr.
North Charleston, South Carolina, 29405
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
National Clin Res Inc.
Richmond, Virginia, 23294
Endo Res Solutions Inc
Roswell, Georgia, 30076
Texas Diabetes & Endocrinology, P.A._Austin
Round Rock, Texas, 78681
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
Chrysalis Clinical Research
St. George, Utah, 84790
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
About this study
Official title: Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
- Conditions
- Obesity
- Being tested
- Semaglutide 2.4 mg and NNC0165-1875 2.0 mg, Semaglutide 2.4 mg and placebo 2.0 mg, Semaglutide 2.4 mg and NNC0165-1875 1.0 mg, Semaglutide 2.4 mg and placebo 1.0 mg
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mg and NNC0165-1875 2.0 mgDrug
NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and placebo 2.0 mgDrug
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and NNC0165-1875 1.0 mgDrug
NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Semaglutide 2.4 mg and placebo 1.0 mgDrug
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 2.4 mg and NNC0165-1875 2.0 mg | Experimental | Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg Receives: Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg |
| Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg) | Placebo comparator | Participants will receive placebo as an add on to semaglutide 2.4 mg. Receives: Drug: Semaglutide 2.4 mg and placebo 2.0 mg |
| Semaglutide 2.4 mg and NNC0165-1875 1.0 mg | Experimental | Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg Receives: Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg |
| Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg) | Placebo comparator | Participants will receive placebo as an add on to semaglutide 2.4 mg. Receives: Drug: Semaglutide 2.4 mg and placebo 1.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Measured: Part 1: From time of dosing (day 1) to follow-up (week 24)
Part 2b: Percentage Change in Body Weight
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2: Randomisation (week 32), end of treatment (week 48)
Secondary outcomes (13)
Part 2b: Change in Body Weight (kg)
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Plasma Glucose (FPG)
Change in FPG (measured in millimoles per liter [mmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Insulin
Change in fasting insulin (measured in picomoles per liter [pmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Waist Circumference
Change in waist circumference (measured in centimeter [cm]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: From randomisation (week 32) to end of the trial (week 56)
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Measured: From randomisation (week 32) to end of the trial (week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 Jul 2021
- Primary completion6 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969939
- Sponsor's protocol ID
- NN9775-4708
- Other IDs
- U1111-1254-9046
- Status last verified
- Jan 2026
- First submitted
- 9 Jul 2021
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT04969939
- Acronym / sponsor ID
- NN9775-4708
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 8 Jan 2026
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 a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 2.4 mg and NNC0165-1875 2.0 mg | Experimental | Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mgParticipants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg |
| Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg) | Placebo comparator | Drug: Semaglutide 2.4 mg and placebo 2.0 mgParticipants will receive placebo as an add on to semaglutide 2.4 mg. |
| Semaglutide 2.4 mg and NNC0165-1875 1.0 mg | Experimental | Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mgParticipants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg |
| Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg) | Placebo comparator | Drug: Semaglutide 2.4 mg and placebo 1.0 mgParticipants will receive placebo as an add on to semaglutide 2.4 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.
Key exclusion criteria (3 listed)
- HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory 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 |
|---|---|---|
| Semaglutide 2.4 mg and NNC0165-1875 2.0 mgNNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached. | Drug | Semaglutide 2.4 mg and NNC0165-1875 2.0 mg |
| Semaglutide 2.4 mg and placebo 2.0 mgNNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached. | Drug | Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg) |
| Semaglutide 2.4 mg and NNC0165-1875 1.0 mgNNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached. | Drug | Semaglutide 2.4 mg and NNC0165-1875 1.0 mg |
| Semaglutide 2.4 mg and placebo 1.0 mgNNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached. | Drug | Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg) |
Primary outcome
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: Part 1: From time of dosing (day 1) to follow-up (week 24)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Part 2b: Percentage Change in Body Weight
Time frame: Part 2: Randomisation (week 32), end of treatment (week 48)
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
13 secondary outcomes
Part 2b: Change in Body Weight (kg)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Plasma Glucose (FPG)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Insulin
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Waist Circumference
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
Time frame: From randomisation (week 32) to end of the trial (week 56)
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
Time frame: From randomisation (week 32) to end of the trial (week 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. 1452) study director
Novo Nordisk A/S
25 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 Semaglutide 2.4 mg and NNC0165-1875 2.0 mg and Semaglutide 2.4 mg and NNC0165-1875 1.0 mg in people with Obesity, run by Novo Nordisk A/S at 25 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 3 inclusion and 3 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 1: Number of Treatment-emergent Adverse Events (TEAEs) (time frame: Part 1: From time of dosing (day 1) to follow-up (week 24)). 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 8 Jan 2026.