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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1203-6796 | Other Identifier | World Health Organization (WHO) |
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The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese. Both study medicines have been investigated on their own. The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. Participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). Participants will get 2 injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. The study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. Participants will have 28 clinic visits with the study staff and some will be overnight visits. Participants will be asked about their health, medical history and habits including mental health questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0174-0833+Semaglutide | Experimental | Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks. |
|
| Placebo (NNC0174-0833)+Semaglutide | Active Comparator | Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0174-0833 | Drug | Participants will receive increasing dose levels of 0.16 mg, 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg of NNC0174-0833 (subcutaneous [s.c.], in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. Each participant will only be given one dose level. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of events | From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state | Measured in nmol*h/L | From last dose (Day 134) until end of treatment (Day 141) |
| Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33894838 | Result | Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021 May 8;397(10286):1736-1748. doi: 10.1016/S0140-6736(21)00845-X. Epub 2021 Apr 22. |
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According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
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| Semaglutide | Drug | Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. |
|
| Placebo (NNC0174-0833) | Drug | Participants will receive once weekly injections of NNC0174-0833 matched placebo. |
|
Measured in nmol/L |
| From last dose (Day 134) until end of treatment (Day 141) |
| AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state | Measured in nmol*h/L | From last dose (Day 134) until end of treatment (Day 141) |
| Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state | Measured in nmol/L | From last dose (Day 134) until end of treatment (Day 141) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |