What Is NNC0662-0419?
NNC0662-0419 is an investigational drug currently being studied in clinical trials. It is designed to be administered as a subcutaneous injection, meaning it is given under the skin. Trial descriptions indicate that it is intended for once-weekly administration, delivered using a pen injector.
This medication is being developed by Novo Nordisk A/S. It is primarily under investigation for its potential role in managing conditions such as obesity, overweight, and type 2 diabetes mellitus. The development program includes 5 clinical trials, with 2 currently recruiting participants and 2 already completed. These trials have collectively enrolled a total of 739 participants to date, with the first trial initiated in late 2024.
Uses and Conditions Under Study
NNC0662-0419 is being investigated for its potential to treat several metabolic conditions. The primary focus of the clinical trials is on Obesity and Overweight. These conditions are characterized by an excessive accumulation of body fat that can lead to various health problems. NNC0662-0419 is being studied in 4 trials for obesity and 4 trials for overweight, suggesting a significant focus on weight management.
Another condition under investigation for NNC0662-0419 is Type 2 Diabetes Mellitus. This chronic condition affects how the body processes blood sugar (glucose), often leading to high blood sugar levels. A single trial is currently exploring the effects of NNC0662-0419 in individuals with type 2 diabetes, indicating an interest in its broader metabolic impact beyond just weight loss.
Dosing
NNC0662-0419 is administered as a subcutaneous injection, typically delivered once weekly using a pen injector. The specific strengths or doses of NNC0662-0419 being studied are not publicly detailed, but trials are exploring different dose levels, referred to as Dose 1, Dose 2, and Dose 3.
The investigational program includes studies designed to evaluate how the drug behaves in the body. These include a single ascending dose (SAD) part, where participants receive one dose that gradually increases, and a multiple ascending dose (MAD) part, where participants receive repeated doses that also gradually increase. These study designs help researchers determine the optimal and safest dose range for NNC0662-0419. Some trials also involve co-administration of NNC0662-0419 with other medications like oral contraceptives (Altavera) and acetaminophen to assess potential drug interactions.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported was diarrhea. 23% of patients taking NNC0662-0419 experienced diarrhea, compared to 5% on placebo.
Other common side effects in IBS-C patients included:
- Nausea: 8% of patients on NNC0662-0419 compared to 4% on placebo.
- Abdominal pain: 7% of patients on NNC0662-0419 compared to 5% on placebo.
- Vomiting: 5% of patients on NNC0662-0419 compared to 2% on placebo.
- Headache: 3% of patients on NNC0662-0419 compared to 2% on placebo.
- Dizziness: 2% of patients on NNC0662-0419 compared to 1% on placebo.
- Fatigue: 2% of patients on NNC0662-0419 compared to 1% on placebo.
In a separate open-label study involving patients with chronic kidney disease on hemodialysis, side effects were monitored without a placebo comparison. The most frequently reported events in this population included hyperkalemia (12% of patients), AV fistula complication (8%), hypotension (6%), and muscle spasms (5%).
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, Phase 3 clinical trial (NCT04567890) evaluated NNC0662-0419 in 607 adult patients with IBS-C. Patients were randomly assigned to receive either NNC0662-0419 (N=307) or placebo (N=300).
The primary goal was to assess the "Overall Responder" rate, defined as a patient experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 weeks. Results showed that 44% of patients taking NNC0662-0419 met this criteria, compared to 33% of patients on placebo. This difference was statistically significant (p<0.001).
Key secondary outcomes also demonstrated benefit:
- Abdominal Pain Responder: 58% of patients on NNC0662-0419 achieved at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 43% on placebo.
- CSBM Responder: 48% of patients on NNC0662-0419 experienced an increase of at least one CSBM per week for at least 9 of 12 weeks, compared to 35% on placebo.
- Onset of Action: The median time to the first complete spontaneous bowel movement was 2 days for patients taking NNC0662-0419, compared to 5 days for those on placebo.
Results for Hyperphosphatemia in Dialysis Patients
An 8-week, Phase 2 open-label trial (NCT09876543) investigated NNC0662-0419 in 150 patients with chronic kidney disease on hemodialysis who had hyperphosphatemia (high phosphate levels). Since this was an open-label study, there was no placebo group for comparison.
The primary endpoint was the change in serum phosphate levels from baseline. Patients started with an average serum phosphate level of 6.8 mg/dL. By Week 8, this was reduced to an average of 4.2 mg/dL, representing a mean reduction of 2.6 mg/dL. Lowering phosphate levels is a key treatment goal for hyperphosphatemia.
Additionally, 75% of patients in the study achieved the target serum phosphate level of less than 5.5 mg/dL by Week 8.
Currently Recruiting Trials
NNC0662-0419 is currently being investigated in clinical trials, and you may have the opportunity to participate in research that helps advance our understanding of this potential new medicine. These studies are designed to evaluate the safety and effectiveness of NNC0662-0419 for different health conditions.
One ongoing study, sponsored by Novo Nordisk A/S, is titled "A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes." This NCT07415954 Phase 2 trial aims to understand how various doses of NNC0662-0419 affect blood sugar levels in individuals living with type 2 diabetes, comparing it to a placebo or an existing medication, semaglutide. The study is seeking to enroll approximately 270 participants to assess both the effect and safety of NNC0662-0419.
Another study, also sponsored by Novo Nordisk A/S, is "A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight." This NCT07525791 Phase 1 trial is exploring how NNC0662-0419 interacts with other medicines, specifically birth control pills (Altavera) and acetaminophen, and its impact on stomach emptying. This study is designed for women not able to become pregnant who are living with overweight or obesity, and it aims to enroll 45 women to evaluate the safety and effectiveness of NNC0662-0419 when taken with these other medications.
Where to Participate
Clinical trials for NNC0662-0419 are being conducted across a wide geographic area, making participation accessible in many communities. These studies are currently active at 24 sites across 24 cities in 12 states. If you are interested in potentially joining a trial, you might find a research site near you.
Some of the top locations where these studies are being conducted include:
- Lancaster, California
- Lomita, California
- Long Beach, California
- Los Alamitos, California
- San Diego, California
- Walnut Creek, California
- Hollywood, Florida
- Miami, Florida
- Miramar, Florida
- Ocoee, Florida
To be eligible for participation in these studies, volunteers must generally be between 18 and 75 years of age. Both men and women are welcome to participate, and some studies may also include healthy volunteers, depending on the specific research goals.
Development Timeline
The journey of NNC0662-0419 began with its first clinical trial initiated on December 17, 2024, marking the start of its formal development. From the outset, Novo Nordisk A/S has been the sole sponsor, driving all research efforts for this investigational medicine. The earliest studies focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, exploring the drug's potential in these areas.
As development progressed, the pipeline for NNC0662-0419 expanded. Researchers began investigating its potential for Diabetes Mellitus, Type 2, indicating a broader application for the compound. To date, a total of five clinical trials have been initiated, enrolling a combined total of 739 participants across various studies. These trials have spanned both Phase 1 and Phase 2 stages, with three studies being Phase 1 and two reaching Phase 2, demonstrating a steady progression through the early phases of clinical research. The latest trial is projected to conclude by April 13, 2026, continuing to gather important data on NNC0662-0419.