Cagrilintide for Obesity

Recruiting at 1 trial location

Overseen By Novo Nordisk

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Amylin, Calcitonin receptor agonists

Disqualifiers: Liver impairment, Renal impairment, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new study medicine to treat individuals who are overweight or have obesity. Researchers aim to determine the medicine's safety and understand its behavior in the body. Participants will be randomly assigned to receive either the new study medicine, an existing medicine called cagrilintide (also known as NNC0174-1213), or a placebo (a dummy medicine with no active ingredients). Men with a body mass index (BMI) between 27 and 34.9, and who weigh at least 80 kilograms, may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cagrilintide, one of the treatments in the trial, is generally well-tolerated by adults who are overweight or have obesity. Previous research found that participants taking cagrilintide lost more weight than those on a placebo, suggesting the treatment's effectiveness. However, all medications can have side effects.

For the new study medicine, NNC0174-1213, limited safety information is available because it remains in early testing. Researchers are still assessing its safety for people. In early trials like this one, treatments are typically administered in small doses to observe reactions and check for side effects. If the treatment progresses through this stage without major safety issues, it is usually considered well-tolerated.

Prospective participants should know that researchers will closely monitor health and safety throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cagrilintide for obesity because it represents a novel approach compared to the current standard treatments, such as lifestyle changes, medications like orlistat, and GLP-1 receptor agonists. Most existing treatments focus on appetite suppression or calorie absorption reduction, but Cagrilintide targets a different mechanism. It mimics a hormone called amylin, which is involved in regulating appetite and slowing gastric emptying, potentially enhancing the feeling of fullness. This unique mechanism might offer a new pathway for effective weight management, providing hope for better outcomes in obesity treatment.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that cagrilintide can aid weight loss in people with obesity. In one study, participants who took cagrilintide lost an average of 12.5 kg, or about 11.8% of their body weight. Another study found that combining cagrilintide with semaglutide resulted in significant weight loss compared to a placebo. These findings offer promising options for those seeking weight loss solutions. In this trial, participants may receive either cagrilintide or NNC0174-1213, which remains under investigation and may also assist with weight management in a similar manner. ^{1 3 4 5 6}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for men aged 18-55 with a BMI of 27.0 to 34.9 and weight over 80 kg, who are generally healthy based on medical exams. It's not for those allergic to the drugs being tested, with kidney issues (eGFR <75), recent other drug trials, diabetes (HbA1c >=6.5%), significant weight changes or dieting within the last three months, certain blood parameter abnormalities, or liver problems.

Inclusion Criteria

I am male.

My BMI is between 27.0 and 34.9.

My body weight is 80 kg or more.

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products

My kidney function is reduced with an eGFR below 75.

Exposure to an investigational medicinal product within 2 months or 5 half-lives before screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single ascending dose (SAD) of NNC0174-1213, cagrilintide, or placebo administered to participants

6 weeks

Multiple visits for dose administration and monitoring

Treatment Part B

Multiple ascending doses (MAD) of NNC0174-1213, cagrilintide, or placebo administered to participants

9 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0174-1213

Trial Overview The study tests NNC0174-1213 A and Cagrilintide B against a placebo in overweight or obese individuals to assess safety and how they work in the body over about one year. Participants will be randomly assigned to receive either the new medicines or a dummy medicine without active ingredients.

How Is the Trial Designed?

Group I: Part B: Placebo Experimental Treatment 3 Interventions

Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.

Group II: Part B: NNC0174-1213 (MD1-MD5) Experimental Treatment 3 Interventions

Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.

Group III: Part B: Cagrilintide (MDA) Experimental Treatment 3 Interventions

Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.

Group IV: Part A: Placebo Experimental Treatment 3 Interventions

Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.

Group V: Part A: NNC0174-1213 (SD1-SD5) Experimental Treatment 3 Interventions

Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.

Group VI: Part A: Cagrilintide (SDA and SDB) Experimental Treatment 3 Interventions

Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Published Research Related to This Trial

In a study of 258 individuals with obesity or overweight in Switzerland, 71.3% of those receiving reimbursed liraglutide 3.0 mg achieved significant weight loss targets at Week 16, indicating its efficacy in real-world settings.

By Month 10, participants who met the initial weight loss criteria experienced an average total weight loss of 12.4% from baseline, demonstrating that liraglutide can lead to clinically meaningful weight reduction over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss and treatment patterns in a real-world population of adults receiving liraglutide 3.0 mg for weight management in routine clinical practice in Switzerland (ADDRESS study). Schultes, B., Timper, K., Cavadini, G., et al.[2023]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Liraglutide and semaglutide, GLP-1 receptor mimetics, have been approved for weight management in obese individuals, showing promising results in Phase III clinical trials.

Tirzepatide, a GLP-1R and GIPR co-agonist, has received Fast Track designation for obesity management and may offer fewer side effects, suggesting it could be a more sustainable option for long-term weight management compared to existing GLP-1R mimetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. Lafferty, RA., Flatt, PR., Irwin, N.[2023]

In the LEADER trial involving 9,340 patients with advanced type 2 diabetes, liraglutide significantly reduced the risk of major cardiovascular events, including death from cardiovascular causes, with a hazard ratio of 0.87 over a median follow-up of 3.8 years.

While liraglutide showed benefits in reducing cardiovascular and nephropathy events, it may be harmful for patients with severe heart failure due to an increase in heart rate, indicating a need for caution in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Effects of Liraglutide. Mikhail, N.[2019]

Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and orlistat, particularly at a dosage of 3 mg daily.

In addition to weight loss, liraglutide has been associated with significant health improvements, including reductions in waist circumference, blood pressure, and better lipid profiles, making it a beneficial option for patients with or without type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. Moore, KG., Shealy, K., Clements, JN.[2022]

In a phase 2 study involving 474 participants with class II/III obesity, JNJ-64565111, a dual agonist, led to significant weight loss compared to placebo, with reductions of up to 10.0% in body weight at week 26.

While JNJ-64565111 was effective in reducing weight in a dose-dependent manner, it also resulted in a higher incidence of treatment-emergent adverse events, particularly nausea and vomiting, compared to both placebo and liraglutide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of glucagon-like peptide-1/glucagon receptor co-agonist JNJ-64565111 in individuals with obesity without type 2 diabetes mellitus: A randomized dose-ranging study. Alba, M., Yee, J., Frustaci, ME., et al.[2022]

Liraglutide significantly reduces visceral fat and liver fat in adults, regardless of whether they have type 2 diabetes, based on a meta-analysis of 16 clinical trials involving 845 participants.

To effectively reduce visceral fat, liraglutide should be administered at a dosage of at least 1.8 mg/day for a duration of 16 to 40 weeks, with mild gastrointestinal issues being the most common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of liraglutide on reducing visceral and ectopic fat in adults with or without type 2 diabetes mellitus: A systematic review and meta-analysis. He, F., Chen, W., Xu, W., et al.[2023]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2502081

Coadministered Cagrilintide and Semaglutide in Adults ... Cagrilintide–semaglutide provided significant and clinically relevant body-weight reductions in adults with overweight or obesity, as compared with placebo.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40544432/

Cagrilintide-Semaglutide in Adults with Overweight or ... Once-weekly cagrilintide-semaglutide (at a dose of 2.4 mg each) resulted in a significantly lower body weight than placebo in adults with obesity and type 2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06719011

NCT06719011 | A Study on How NNC0174-1213 Works in ... This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe.

4. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/easd2025/garvey1/documents/Garvey_EASD25_REDEFINE_1_Cagrilintide_Short_oral_with_disclosures.pdf

Efficacy and safety of cagrilintide 2.4 mg in adults with ... Efficacy and safety of cagrilintide 2.4 mg in adults with overweight/obesity: Data from REDEFINE 1. W. Timothy Garvey1*, Lei Liu2, John ...

5. biospace.com biospace.com/press-releases/novo-nordisk-presents-phase-3-data-for-next-generation-amylin-cagrilintide-leading-to-advancement-into-dedicated-clinical-programme

Novo Nordisk presents phase 3 data for next-generation ... Positive results show that the average weight loss was 12.5 kg (11.8% body weight reduction) with cagrilintide compared to 2.5 kg (2.3%) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06719011

NCT06719011 | A Study on How NNC0174-1213 Works in ... This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, ...