NNC0487-0111 and Birth Control Pills for Obesity

Overseen By Novo Nordisk

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Herbal supplements

Disqualifiers: Gastrointestinal disorders, Major stomach surgery, others

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

Compensation: Varies

Number of Visits: Unknown

43 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

You may need to stop taking certain medications. The trial excludes those using drugs that interfere with metabolic CYP pathways, like St. John's Wort, ginseng, garlic, milk thistle, and echinacea, within 14 days before screening. Routine vitamins and occasional use of acetaminophen, ibuprofen, and aspirin are allowed.

What data supports the idea that NNC0487-0111 and Birth Control Pills for Obesity is an effective drug?

The available research does not provide specific data on the effectiveness of NNC0487-0111 and Birth Control Pills for Obesity. Instead, it discusses other drugs like orlistat, sibutramine, and phentermine, which have shown to help with weight loss. For example, orlistat can lead to a weight loss of 5-8 kg, while phentermine can result in a 5-15% weight loss. These drugs are compared to a placebo, which means a treatment with no active drug, and they show better results in helping people lose weight. However, there is no direct information on NNC0487-0111 and Birth Control Pills for Obesity in the provided data. ^{1 2 3 4 5}

What safety data is available for the treatment NNC0487-0111 (Amycretin, NN-9487, NN9487, NNC-04870111)?

The provided research does not mention NNC0487-0111 or its other names directly, so specific safety data for this treatment is not available in the given documents. The research focuses on other anti-obesity medications and their associated adverse events, such as phentermine/topiramate, liraglutide, orlistat, lorcaserin, naltrexone/bupropion, sibutramine, and rimonabant. These studies highlight various adverse events like cardiovascular issues, gastrointestinal problems, and psychiatric disorders, but do not provide information on NNC0487-0111. ^{6 7 8 9 10}

Is the drug NNC0487-0111 a promising treatment for obesity?

The drug NNC0487-0111, also known as Amycretin, is considered promising for treating obesity because it is part of ongoing research and development efforts to find effective weight management solutions. While specific details about its effectiveness are not provided in the articles, the fact that it is being studied suggests potential benefits in managing obesity. ^{3 4 11 12 13}

What is the purpose of this trial?

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for women who cannot become pregnant and are dealing with obesity. Participants will take a daily tablet for 18 weeks, followed by injections in the abdomen for 9 weeks. The study lasts about 35 weeks.

Inclusion Criteria

Body mass index (BMI) between 25.0 and 39.9 kg/m^2 at screening

Considered to be generally healthy based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator

I cannot become pregnant.

Exclusion Criteria

I do not have serious stomach or bowel problems that affect how my body absorbs medicine.

I have no health issues that prevent me from using Microgynon.

Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oral Treatment

Participants receive oral dosing of NNC0487-0111, escalating from dose 1 to dose 2, for 18 weeks

18 weeks

Subcutaneous Treatment

Participants receive subcutaneous injections of NNC0487-0111, escalating from dose 3 to dose 4, for 9 weeks

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-8 weeks

Treatment Details

Interventions

• NNC0487-0111

Trial Overview The study tests NNC0487-0111's impact on the effectiveness of birth control pills and stomach emptying in obese women. It involves taking an oral contraceptive alongside the study drug, first orally then via injection.

Participant Groups

Group I: NNC0487-0111 Experimental Treatment 4 Interventions

Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 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

Findings from Research

Phentermine is an effective short-term weight loss medication that can lead to a 5-15% reduction in weight, but it has common side effects like dry mouth and increased blood pressure, and tolerance may develop with prolonged use.

Orlistat, which is not absorbed systemically and thus has fewer systemic side effects, can also lower cholesterol but is limited by its frequent dosing and gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic options for the treatment of obesity. Campbell, ML., Mathys, ML.[2019]

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]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

There are three main drugs approved for long-term obesity treatment: orlistat (5-8 kg weight loss but with gastrointestinal side effects), lorcaserin (4-7 kg weight loss with few side effects), and a combination of phentermine and topiramate (8-10 kg weight loss, but requires pregnancy verification).

For patients with chronic diseases like diabetes or depression, it's important to choose medications that not only treat the condition but also promote weight loss, as some drugs can cause weight gain or have a neutral effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. Bray, GA., Ryan, DH.[2014]

A review of nine systematic reviews found that pharmacological therapies for obesity, including liraglutide, orlistat, and naltrexone-bupropion, are effective in reducing weight compared to placebo.

Orlistat not only aids in weight loss but also significantly improves metabolic markers like fasting blood glucose and cholesterol levels, although it is associated with gastrointestinal side effects such as diarrhea and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Treatment for Obesity in Adults: An Umbrella Review. Khalil, H., Ellwood, L., Lord, H., et al.[2020]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

In a review of 28 trials involving orlistat, sibutramine, and rimonabant, rimonabant and orlistat were associated with a significantly higher risk of discontinuation due to adverse events, with rimonabant having the highest risk ratio of 2.00.

The most common reasons for discontinuation were gastrointestinal issues for orlistat (40%) and psychiatric issues for rimonabant (47%), highlighting the importance of monitoring side effects in patients using these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Johansson, K., Neovius, K., DeSantis, SM., et al.[2018]

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]

Phentermine/topiramate extended-release (PHEN/TPM ER) and lorcaserin are effective new medications for long-term weight management, with PHEN/TPM ER showing superior weight loss compared to lorcaserin based on phase III trials involving multiple participants.

Both medications are generally well-tolerated, but they come with specific safety concerns: PHEN/TPM ER may cause increased heart rate and psychiatric effects, while lorcaserin has risks of valvulopathy and cognitive impairment, necessitating careful monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and safety of the new anti-obesity medications. Hainer, V., Aldhoon-Hainerová, I.[2021]

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

Obese women are at a higher risk for unintended pregnancies and thromboembolic events, making careful selection of contraceptive methods crucial; progestin-only contraceptives and intra-uterine devices are preferred options.

While obesity does not increase the failure rate of most contraceptive methods, bariatric surgery can complicate contraceptive choices due to potential gastrointestinal malabsorption, making oral contraceptives less reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contraception and obesity]. Lobert, M., Pigeyre, M., Gronier, H., et al.[2016]

Women with obesity were primarily prescribed progestin-only pills (44%) compared to normal-weight women who were mostly given combined hormonal contraception (60%), highlighting a significant difference in contraceptive prescribing practices.

Women with obesity had a higher discontinuation rate of contraceptive methods within the first year (33% vs. 25% for normal-weight women), with bleeding disturbances being the most common reason for stopping, indicating potential challenges in adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of prescription and discontinuation of contraceptives for Swedish women with obesity and normal-weight women. Sundell, M., Ginstman, C., Månsson, A., et al.[2019]

Most high-quality studies indicate that oral contraceptive pills are generally effective for obese women, similar to their effectiveness in non-obese women, although data for women with severe obesity is limited.

Non-oral contraceptives typically maintain their effectiveness in obese women, but the combined hormonal patch and oral levonorgestrel emergency contraception may be less effective in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal contraception and obesity. Simmons, KB., Edelman, AB.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacologic options for the treatment of obesity. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Treatment for Obesity in Adults: An Umbrella Review. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. [2018]

8. England 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). [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Tolerability and safety of the new anti-obesity medications. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Contraception and obesity]. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Patterns of prescription and discontinuation of contraceptives for Swedish women with obesity and normal-weight women. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Hormonal contraception and obesity. [2022]