Written By: Dr. Nevathaa Natraj, PharmD
Reviewed By: Pharmacally Editorial Team
The Story behind Ozempic
Decades of groundbreaking scientific discovery fuel Ozempic’s discovery journey. In the late 1970s, researchers discovered a natural hormone called glucagon-like peptide-1 (GLP-1). This hormone plays a vital role in managing blood sugar by encouraging the body to release insulin after meals.
However, GLP-1 breaks down swiftly for direct use as a medicine. Scientists spent years developing a stable and effective artificial version that patients could rely on.
Building on earlier drugs like liraglutide, Novo Nordisk’s researchers, including Jesper Lau and Paw Bloch, engineered semaglutide, the active ingredient in Ozempic.
Yes, you heard it right!
In order to deliver a similar artificial hormonal effect that stands long in the body and , that it tends to mimic GLP-1 hormone, they made small, precise changes to the hormone’s structure. These adjustments help the hormone resist rapid breakdown, allowing it to stay active in the body much longer.
Importantly, these modifications do not compromise the hormone’s powerful ability to lower blood sugar. Thus Ozempic was made and understood well about!
How Ozempic Helps
By mimicking the natural GLP-1 hormone, Ozempic helps the body in three important ways:
- It boosts insulin release when blood sugar is high,
- Lowers the production of glucagon (which raises blood sugar), and
- Slows down the emptying of the stomach to reduce appetite.
This triple action not only keeps blood sugar levels steady but also aids in weight management a key factor for many individuals with diabetes.
Why Ozempic Matters
Thanks to years of meticulous research and smart pharmaco chemistry, Ozempic has turned a fragile natural hormone into a convenient, effective, once-weekly treatment. Since its clinical trials began in 2014 with SUSTAIN 1 trial, it has helped millions worldwide gain better control over their diabetes and improve their overall health.
With its arrival in India, more patients now have access to this innovative therapy that addresses both blood sugar and weight tackling two of the biggest challenges in diabetes care. Thus, Ozempic was born.
About Ozempic- what FDA has got to say?
Ozempic (semaglutide) is a once-weekly injectable medication from Novo Nordisk designed to improve blood sugar control in adults with type 2 diabetes.
It also reduces the risk of major cardiovascular events like heart attack and stroke in high-risk patients.
As we already know from above it works by activating the GLP-1 receptor,
Yes! Ozempic boosts insulin secretion when glucose levels are high, suppresses excess glucagon release, and slows gastric emptying. This combined action improves post-meal blood sugar levels and helps reduce appetite, supporting gradual weight loss.
Patients appreciate Ozempic convenient once-weekly dosing, which improves adherence and simplifies long-term diabetes management.
Treatment typically starts at 0.25 mg per week and gradually increases to 0.5 mg, 1 mg, or 2 mg based on individual response and tolerance. The medication is administered subcutaneously in the abdomen, thigh, or upper arm, with or without food.
Common side effects include gastrointestinal symptoms such as nausea and diarrhea, which usually subside over time. Healthcare providers monitor patients for rare but serious risks like pancreatitis, kidney function changes, and thyroid concerns to ensure safe and effective use.
About Type 2 Diabetes Mellitus
Type 2 diabetes mellitus is a chronic, progressive metabolic disorder. That is characterized by insulin resistance and impaired pancreatic β-cell function. These dysfunctions lead to elevated blood glucose levels and long-term complications. Thus affecting the kidneys, eyes, nerves, and heart.
The condition typically develops in adults and is strongly linked to lifestyle factors such as poor diet, physical inactivity, and excess body weight, although genetic predisposition also has a high role to play.
Ozempic (semaglutide), a GLP-1 receptor agonist developed by Novo Nordisk, is specifically designed to target the underlying pathophysiology of type 2 diabetes.
By activating the GLP-1 receptor, Ozempic enhances glucose-dependent insulin secretion, suppresses inappropriate glucagon release, and slows gastric emptying, yes the triple way action.
These actions help lower postprandial blood sugar, reduce appetite, and support weight loss key goals in modern day diabetes management.
Beyond glycemic control, Ozempic have also shown significant cardiovascular benefits in patients with established heart disease.
Clinical trials demonstrate a reduced risk of major adverse cardiovascular events (MACE), including heart attack and stroke, making Ozempic a valuable option for patients facing both metabolic and cardiovascular risks.
Clinical Evidence Supporting FDA Approval of Ozempic (Semaglutide)
The FDA approved Ozempic (semaglutide) in December 2017 as a once-weekly GLP-1 receptor agonist for adults with type 2 diabetes mellitus.
Novo Nordisk based this approval on a comprehensive clinical program, primarily the SUSTAIN Phase 3 trial series, which assessed Ozempic ability to control blood sugar, promote weight loss, and provide cardiovascular protection across diverse patient groups.
SUSTAIN-1 to SUSTAIN-5: Glycemic Control and Weight Reduction
Researchers conducted randomized, double-blind, placebo- or active-controlled trials on patients who were either new to treatment or had insufficient control with oral antidiabetic drugs. These studies compared Ozempic with medications like sitagliptin and exenatide.
- Ozempic significantly lowered HbA1c levels.
- In SUSTAIN-1, patients taking 1 mg of semaglutide reduced their HbA1c by an average of 1.5% over 30 weeks.
- Patients also lost clinically meaningful weight, with an average reduction of 4.3 kg in the same trial.
- Higher doses produced greater metabolic improvements, showing dose-dependent effects.
These results demonstrate that Ozempic effectively addresses both high blood sugar and excess weight, two central challenges in managing type 2 diabetes.
SUSTAIN-6: Cardiovascular Outcomes Trial
In the SUSTAIN-6 trial, researchers evaluated Ozempic’s effect on cardiovascular risk in patients with type 2 diabetes who had existing cardiovascular disease. The trial involved over 3,000 participants and lasted two years.
- Ozempic lowered the risk of major adverse cardiovascular events (MACE) by 26% compared to placebo.
- This included reductions in nonfatal heart attacks, nonfatal strokes, and cardiovascular deaths.
These findings supported Ozempic’s expanded indication for cardiovascular risk reduction, highlighting its dual role in managing both metabolic and cardiac health.
Understanding the Safety of Ozempic
Ozempic has been carefully studied in many clinical trials, and overall, it is considered safe and well tolerated by most people. Like any medicine, it can cause side effects, but knowing what to expect helps you feel more comfortable and in control.
The most common side effects with Ozempic are mild and usually affect the stomach or digestion. People might feel a bit nauseous, have some diarrhea, or experience stomach discomfort, especially when they first start taking it or when their dose is increased. These symptoms often improve as the body gets used to the medicine.
Doctors keep a close eye on important health aspects during treatment. For example, there is a small chance of inflammation of the pancreas (pancreatitis), so any severe belly pain should be reported right away. Some patients might notice changes in vision if they have existing eye issues related to diabetes, so regular eye check-ups are important.
Ozempic can also affect the kidneys, especially if you have severe nausea or vomiting that causes dehydration. That’s why staying hydrated and informing your doctor about any side effects is key.
One special precaution involves the thyroid. Animal studies found a possible link between semaglutide (the active ingredient in Ozempic) and thyroid tumors, though this hasn’t been seen in people. Because of this, Ozempic is not recommended for anyone with a personal or family history of certain thyroid cancers.
Sometimes, Ozempic can slow how quickly food leaves the stomach, which might change how your body absorbs other medicines. Your healthcare provider will consider this when managing your treatment.
Most people benefit from Ozempic without serious problems, and the benefits for controlling blood sugar and protecting heart health can be significant. Open communication with your doctor helps make sure your treatment is both safe and effective.
Clinical Takeaway for Healthcare Professionals
Ozempic offers a convenient once-weekly injection with proven benefits in blood sugar control, weight loss, and cardiovascular protection. Its GLP-1 receptor agonist activity fits well within current guidelines for comprehensive type 2 diabetes care, particularly for patients with increased cardio metabolic risk.
Prescribing Instructions for Physicians
Dosing and Administration
Start Ozempic at 0.25 mg once weekly for 4 weeks to improve tolerability. This dose is not intended for glycemic control.
After 4 weeks, increase to 0.5 mg once weekly, and if needed, titrate to 1 mg or 2 mg at intervals of at least 4 weeks.
Ozempic is administered subcutaneously in the abdomen, thigh, or upper arm, at any time of day, with or without food. If a dose is missed, administer within 5 days or skip and resume the regular schedule.
Monitoring Parameters before initiating therapy assess renal function, diabetic retinopathy status, and cardiovascular risk.
During treatment, monitor HbA1c, body weight, blood pressure, and gastrointestinal symptoms, especially during dose escalation.
For patients with pre-existing eye disease, schedule routine ophthalmologic exams, as worsening of diabetic retinopathy was observed in trials like SUSTAIN-6.
Drug Interactions and Absorption Ozempic delays gastric emptying, which may affect the absorption of oral medications. Monitor drugs with narrow therapeutic windows (e.g., warfarin, levothyroxine). Adjust insulin or sulfonylurea doses to reduce hypoglycemia risk when co-administered. No significant CYP450-mediated interactions have been reported.
Tolerability and Adherence Gastrointestinal symptoms such as nausea, vomiting, and diarrhea are the most common side effects, especially during dose escalation.
In the SUSTAIN FORTE trial, GI events occurred in 30–34% of patients, with low discontinuation rates (3–4%).
Gradual titration and patient education significantly improve long-term adherence, which remains high in real-world settings.
Access and Affordability Ozempic is widely available through retail and specialty pharmacies. Patient assistance programs and formulary inclusion have improved access globally.
Prescribers could verify insurance coverage, and consider step therapy or prior authorization requirements when initiating treatment.
Ozempic continues to gain traction globally, with real-world data confirming its effectiveness in lowering HbA1c, supporting weight loss, and reducing cardiovascular risk. Its safety profile aligns with other GLP-1 receptor agonists, with gastrointestinal symptoms being the most common side effects. Clinicians are advised to monitor for pancreatitis, retinopathy changes, and thyroid-related risks, especially in high-risk populations.
As access expands through formulary inclusion and patient support programs, Ozempic is becoming a preferred option for many adults with type 2 diabetes. Its impact reaches beyond clinical metrics offering patients a more manageable, empowering way to live with a chronic condition.
Key Opinions
Dr. Vikrant Shrotriya, Managing Director of Novo Nordisk India, described the approval of Ozempic in India as a much-needed step to address the country’s growing burden of type 2 diabetes and obesity. He emphasized that the addition of the injectable semaglutide to Novo Nordisk’s Indian portfolio complements the already available oral form, offering physicians and patients a broader range of therapeutic options. Dr. Shrotriya noted that the company intends to ensure adequate supply before a large-scale rollout, highlighting that launching without guaranteed availability could undermine patient trust and brand reliability.
He also acknowledged that India’s market is highly price-sensitive and said Novo Nordisk will adapt its pricing strategy to reflect local affordability while maintaining quality standards. Regarding long-term access, Dr. Shrotriya pointed out that semaglutide patent protection in India expires in March 2026, after which generic versions may enter the market, potentially improving affordability and access. He added that the inclusion of semaglutide on the WHO Essential Medicines List underscores global regulatory confidence in the therapy’s clinical relevance and safety profile.
DRUG FACT:
Ozempic’s name was created by Novo Nordisk’s branding and marketing team to be clear, memorable, and easy to pronounce worldwide.
The name carefully reflects the company’s goal to convey strength and approachability for a modern diabetes treatment.Thus earning trust and credibility.
Ozempic name is designed to be clear and approachable, with a smooth, memorable sound that feels modern and trustworthy.
It reflects the drug’s purpose, to support and empower people managing diabetes and weight, without being overly technical or complicated.
References:
Official FDA Ozempic Prescribing Information 2024 – Comprehensive details on dosing, safety warnings, and approved uses of semaglutide.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209637s032lbl.pdf
SELECT Trial Results on Ozempic Cardiovascular Benefits – Evidence of semaglutide’s heart protection in patients with obesity.
https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select
NovoMedLink Guide to Ozempic Dosing and Safety – Expert resource for clinicians on titration and patient management
https://www.novomedlink.com/diabetes/products/treatments/ozempic/dosing.html
Pharmacy Times Expert Commentary on Ozempic Kidney Disease Approval – Insights on semaglutide’s role in chronic kidney disease and cardiovascular risk.
Novo Nordisk Executive Statements on Ozempic FDA Approval – Official commentary from company leadership on Ozempic’s impact.
https://www.novomedlink.com/diabetes/products/treatments/ozempic/dosing.html
MedShadow Patient Stories on Ozempic Use and Side Effects – Real-world patient experiences highlighting benefits and common side effects.
https://medshadow.org/real-people-ozempic-side-effect-stories/
PR Newswire “My Ozempic Era” Patient Testimonials Campaign – Collection of inspirational user stories from diverse patients.
India Today Coverage of Ozempic Market Launch in India – News on the approval and commercial introduction of Ozempic in India.
Applied Clinical Trials REACH Study Comparing Ozempic and Dulaglutide – Real-world data demonstrating cardiovascular risk reduction advantage
Ozempic approved in India, Novo Nordisk country head says ‘much-needed’, India Today, 29 Sept 2025, https://www.indiatoday.in/health/story/ozempic-approved-in-india-novo-nordisk-india-head-calls-it-much-needed-2795317-2025-09-29
Steven P. Marso et al, Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes, N Engl J Med 2016;375:1834-1844, DOI: 10.1056/NEJMoa1607141
Aroda VR, et al, Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. PMID: 30615985.
Sorli, Christopher et al., Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial, The Lancet Diabetes & Endocrinology, Volume 5, Issue 4, 251 – 260