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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-3573 | Other Identifier | World Health Organization (WHO) |
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This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide | Experimental | Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2. |
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| Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide | Experimental | Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2. |
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| Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide | Experimental | Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2. |
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| Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide | Experimental | Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose-dependent Insulinotropic Polypeptide (GIP) | Drug | Participants will receive GIP subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea | Measured as number of events. | From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89) |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of Adverse Events | Measured as number of events. | First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142) |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention(s) or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.
Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).
Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Research Unit | Recruiting | Harrow | Middlesex | HA1 3UJ | United Kingdom |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| Cagrilintide | Drug | Participants will receive Cagrilintide subcutaneously. |
|
| Placebo GIP | Drug | Participants will receive placebo matched to GIP subcutaneously. |
|
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054795 | Incretins |
| C000717792 | cagrilintide |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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