What side effects are associated with this type of intervention?

Common treatments for obesity that involve subcutaneous injections, such as GLP-1 receptor agonists and PCSK9 inhibitors, typically have side effects including mild injection site reactions (e.g., erythema, pain, or bruising). GLP-1 receptor agonists may also cause gastrointestinal issues like nausea, vomiting, and diarrhea. PCSK9 inhibitors can occasionally lead to hypersensitivity reactions, including rash and urticaria. Combination drugs like phentermine-topiramate, taken orally, can cause side effects such as dry mouth, constipation, insomnia, and an increased heart rate. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several subcutaneous injection treatments for obesity, including liraglutide (Saxenda) and semaglutide (Wegovy). Liraglutide, initially approved for type 2 diabetes as Victoza, was later approved for chronic weight management under the brand name Saxenda. Semaglutide, another GLP-1 receptor agonist, was approved for weight management as Wegovy. Both drugs have shown significant efficacy in weight loss and are administered via subcutaneous injection, making them similar to the investigational drug NNC0487-0111.

What other types of research exist?

Promising alternatives to NNC0487-0111 for obesity treatment in 2024 include semaglutide (a GLP-1 receptor agonist), dual GIP/GLP-1 receptor agonists like NNC0090-2746, and bariatric surgery. Discuss these options with your healthcare provider to determine the best treatment plan for you.

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Other

NNC0487-0111 for Obesity

Phase 2

Recruiting

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

Aged 18-55 years (both inclusive) at the time of signing informed consent

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from pre-dose on v33d1 until end of study visit (v37) up to 24 days

Summary

This trial is testing a new medicine called NNC0487-0111, given as an injection under the skin, to see if it is safe and how it works in the body.

Who is the study for?

This trial is for men and women aged 18-55 with a BMI between 27.0 and 39.9, indicating overweight due to excess fat as assessed by the study's doctor. Participants must pass health checks including vital signs, heart tests, and lab tests. Those with conditions affecting safety or protocol adherence, high blood sugar levels (HbA1c ≥6.5%), very low vitamin D, abnormal parathyroid hormone or calcium levels, or significantly elevated amylase/lipase/calcitonin are excluded.

What is being tested?

The trial is testing NNC0487-0111, a new drug given as an under-the-skin injection to see if it's safe and how it works in people with obesity compared to a placebo (a substance with no active drug).

What are the potential side effects?

While specific side effects of NNC0487-0111 aren't listed here, common ones for new obesity treatments can include nausea, headaches, digestive issues like diarrhea or constipation; reactions at the injection site; fatigue; and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-dose on v33d1 until end of study visit (v37) up to 24 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-dose on v33d1 until end of study visit (v37) up to 24 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose on v33d1 until end of study visit (v37) up to 24 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

PART A: Number of treatment emergent adverse events (TEAE)

PARTS B to E: 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 and the corresponding time tmax

PART B to E: Relative change in body weight

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NNC0487-0111Experimental Treatment2 Interventions

Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD)

Group II: PlaceboPlacebo Group2 Interventions

Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NNC0487-0111

2023

Completed Phase 1

~40

Placebo (NNC0487-0111)

2023

Completed Phase 1

~40

0 / 1Eligibility criteria met

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

Subcutaneous injections for obesity, such as GLP-1 receptor agonists (e.g., semaglutide), work by mimicking the incretin hormones that increase insulin secretion, inhibit glucagon release, and slow gastric emptying, leading to reduced appetite and caloric intake. This mechanism is crucial for obesity patients as it directly targets the physiological pathways involved in hunger and satiety, promoting significant weight loss and improving metabolic health. Other treatments, like the combination of phentermine and topiramate, enhance weight loss by suppressing appetite and increasing energy expenditure. These mechanisms are vital for managing obesity, as they help patients achieve and maintain a healthier weight, thereby reducing the risk of obesity-related comorbidities.

Efficacy of subcutaneous semaglutide compared to placebo for weight loss in obese, non-diabetic adults: a systematic review & meta-analysis.[Leptin in the regulation of energy balance].