What is the mechanism of action of this treatment?

Amylin and GLP-1 mimetics, like the investigational drug NNC0487-0111, work by mimicking the body's natural hormones that regulate appetite and satiety. Amylin slows gastric emptying and promotes a feeling of fullness, while GLP-1 enhances insulin secretion, inhibits glucagon release, and also promotes satiety. These mechanisms are crucial for obesity patients as they help reduce food intake and promote weight loss, addressing the core issue of excessive caloric consumption. By targeting these pathways, these treatments can effectively support long-term weight management and improve related metabolic conditions.

What side effects are associated with this type of intervention?

Common treatments for obesity similar to NNC0487-0111 include GLP-1 receptor agonists like liraglutide and semaglutide. Known side effects of these treatments often include gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation. There are also potential risks of pancreatitis and, in rare cases, thyroid C-cell tumors. Patients may experience injection site reactions and, less commonly, gallbladder-related issues like cholelithiasis. It is important to monitor these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, which are similar to the GLP-1 mimetic component of NNC0487-0111. Liraglutide (Saxenda) is one such drug, approved for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with at least one weight-related condition. Liraglutide works by mimicking the GLP-1 hormone, which helps regulate appetite and food intake. Another GLP-1 receptor agonist, semaglutide (Wegovy), has also been approved for weight management in adults with obesity or overweight with comorbidities. These drugs have shown significant efficacy in weight loss and are part of the broader category of incretin-based therapies.

What other types of research exist?

Promising alternatives to NNC0487-0111 for obesity treatment include: <ol> <li>Liraglutide (Saxenda): A GLP-1 receptor agonist that has shown significant weight loss in clinical trials.</li> <li>Semaglutide (Wegovy): Another GLP-1 receptor agonist approved for weight management, demonstrating substantial weight loss in studies.</li> <li>Tirzepatide: A dual GIP and GLP-1 receptor agonist currently under investigation, showing promising results in weight reduction.</li> <li>Setmelanotide (Imcivree): Approved for specific genetic obesity disorders, it targets the melanocortin-4 receptor pathway.</li> </ol>

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GLP-1 and Amylin Analog

NNC0487-0111 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days

Summary

This trial tests a new medicine called NNC0487-0111 that mimics natural hormones to help people feel full. It aims to help those who are overweight or obese manage their weight. The study will check if the medicine is safe and how it affects body weight.

Who is the study for?

This trial is for adults aged 18-55 with a BMI of 25.0 to 39.9 kg/m^2, who are in good health based on medical history, physical exams, and lab tests. It's not for those with certain blood or enzyme abnormalities or other conditions that could risk safety or protocol adherence.

What is being tested?

The study is testing NNC0487-0111, a new medication mimicking hormones amylin and GLP-1 to help reduce body weight by making people feel full. Participants will receive either the drug or placebo in various dosages over single doses up to a daily dose for 12 weeks.

What are the potential side effects?

While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions due to the medicine's similarity to natural hormones which can affect digestion, blood sugar levels, and appetite.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of treatment emergent adverse events (TEAE)

Secondary study objectives

Part A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose

Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part DExperimental Treatment2 Interventions

Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12.

Group II: Part CExperimental Treatment2 Interventions

Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12.

Group III: Part B: Multiple ascending dose (MAD)Experimental Treatment2 Interventions

Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.

Group IV: Part A: Single ascending dose (SAD)Experimental Treatment2 Interventions

Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NNC0487-0111 A

2022

Completed Phase 1

~150

NNC0487-0111 B

2022

Completed Phase 1

~150

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Amylin and GLP-1 mimetics, like the investigational drug NNC0487-0111, work by mimicking the body's natural hormones that regulate appetite and satiety. Amylin slows gastric emptying and promotes a feeling of fullness, while GLP-1 enhances insulin secretion, inhibits glucagon release, and also promotes satiety. These mechanisms are crucial for obesity patients as they help reduce food intake and promote weight loss, addressing the core issue of excessive caloric consumption. By targeting these pathways, these treatments can effectively support long-term weight management and improve related metabolic conditions.

Antiobesity effects of the beta-cell hormone amylin in combination with phentermine or sibutramine in diet-induced obese rats.