Clinical Evidence: The SUSTAIN Trial Program
Ozempic was evaluated across the comprehensive SUSTAIN clinical trial program, encompassing over 10,000 randomized patients globally. The definitive cardiovascular outcome trial, SUSTAIN-6 (published in the New England Journal of Medicine by Marso et al., 2016; 375:1834-1844, DOI: 10.1056/NEJMoa1607141), evaluated 3,297 patients with type 2 diabetes and established cardiovascular disease over 104 weeks.
| Clinical Trial | Cohort (n) | Dose & Regimen | Primary Outcome | Statistical Significance |
|---|---|---|---|---|
| SUSTAIN-6 | 3,297 | Semaglutide 0.5mg or 1.0mg weekly vs Placebo | 26% reduction in 3-point MACE (CV death, nonfatal MI, nonfatal stroke) | HR 0.74 (95% CI 0.58–0.95), p=0.02 |
| SUSTAIN-6 (Stroke) | 3,297 | Semaglutide 0.5mg or 1.0mg weekly vs Placebo | 39% reduction in nonfatal stroke incidence (1.6% vs 2.7%) | HR 0.61 (95% CI 0.38–0.99), p=0.04 |
| SUSTAIN-1 | 388 | Semaglutide 0.5mg / 1.0mg monotherapy vs Placebo | HbA1c change of -1.45% (0.5mg) and -1.55% (1.0mg) | p < 0.0001 vs placebo (-0.02%) |
| SUSTAIN-Forte | 961 | Semaglutide 2.0mg weekly vs Semaglutide 1.0mg | Superior HbA1c reduction (-2.2% vs -1.9%) and weight loss (-6.9kg vs -6.0kg) | p < 0.01 for HbA1c superiority |
Ozempic Dosing & Stepwise Titration Schedule
Ozempic is administered as a once-weekly subcutaneous injection into the abdomen, thigh, or upper arm on the same day each week, with or without meals. Doses are stepped up gradually in 4-week intervals to prevent gastrointestinal side effects:
| Phase | Duration | Weekly Dose | Clinical Purpose |
|---|---|---|---|
| Initiation | Weeks 1–4 | 0.25 mg weekly | Gastrointestinal tolerability phase; not intended for glycemic control. |
| Therapeutic Step 1 | Weeks 5–8 | 0.5 mg weekly | Initial therapeutic dose for glycemic management. |
| Therapeutic Step 2 | Weeks 9–12 | 1.0 mg weekly | Escalation if additional blood sugar control is required. |
| Maximum Maintenance | Week 13+ | 2.0 mg weekly | Approved maximum dose for patients needing intensive glycemic regulation. |
Prescription Ozempic Delivered Direct to Your Door
Complete our clinical evaluation. A state-licensed physician reviews your health history and writes your prescription with zero clinic visits required.
See If You QualifyFDA Safety Profile & Contraindications
Ozempic carries an FDA Boxed Warning for Thyroid C-Cell Tumors. In rodent carcinogenicity studies, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) at clinically relevant exposures. It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.
BOXED WARNING & CONTRAINDICATIONS
- Contraindicated in individuals with a personal or family history of Medullary Thyroid Carcinoma (MTC).
- Contraindicated in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Contraindicated in patients with known hypersensitivity to semaglutide or any components of Ozempic.
- Not for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
The most common adverse reactions reported in clinical trials (at or above 5%) were gastrointestinal: nausea (15.8%–20.3%), diarrhea (8.5%–8.8%), vomiting (5.0%–9.2%), and abdominal pain (5.7%–7.3%). These symptoms are predominantly mild-to-moderate and transient, peaking during initial titration weeks.
How the Telehealth FX Ozempic Program Works
Complete Online Assessment
Fill out our 5-minute metabolic health questionnaire detailing your HbA1c, medical history, and current medications.
Physician Review (Under 24 Hours)
A board-certified physician licensed in your state evaluates your chart, orders any necessary lab markers, and issues your prescription.
Direct Cold-Chain Fulfillment
Your genuine Novo Nordisk Ozempic pen ships in insulated, temperature-monitored packaging via 2-day express courier.
Ongoing Titration & Clinical Support
Regular check-ins with your care team ensure seamless dosage escalation, symptom management, and A1C progress tracking.
Frequently Asked Questions
What is Ozempic and what is it FDA-approved for?
Ozempic® is an injectable prescription medicine containing semaglutide. It is FDA-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events (stroke, heart attack, or cardiovascular death) in adults with type 2 diabetes and established cardiovascular disease.
How much does Ozempic cost through Telehealth FX?
Through Telehealth FX, Ozempic is available at a flat rate of $1,199 per month across all dosage strengths (0.5mg, 1.0mg, and 2.0mg). First-time orders receive an automatic promotional discount saving up to $100 at checkout ($1,099 for your first month). The fee covers your licensed physician evaluation, ongoing care coordination, and free 2-day cold-chain shipping. No hidden membership fees apply.
What were the results of the SUSTAIN-6 clinical trial for Ozempic?
In the landmark SUSTAIN-6 clinical trial (NEJM 2016, n=3,297), once-weekly semaglutide produced a statistically significant 26% hazard reduction in major adverse cardiovascular events (HR 0.74, 95% CI 0.58-0.95, p=0.02) over 104 weeks compared to placebo. Nonfatal stroke was reduced by 39% (p=0.04), alongside mean HbA1c reductions of up to 1.4% and significant body weight reductions.
What is the standard Ozempic dosage titration schedule?
Ozempic begins with an initiation dose of 0.25 mg once weekly for 4 weeks to allow gastrointestinal adaptation. At week 5, the dose escalates to 0.5 mg once weekly. If additional glycemic control is required after at least 4 weeks on 0.5 mg, your clinician may increase your dose to 1.0 mg weekly, and up to a maximum maintenance dose of 2.0 mg weekly.
Is Ozempic eligible for HSA or FSA payment?
Yes. Telehealth FX accepts Health Savings Account (HSA) and Flexible Spending Account (FSA) cards. Because Ozempic is a physician-prescribed clinical medication, full program fees qualify under IRS Section 213(d) medical expense regulations.
What states are eligible for the Telehealth FX Ozempic program?
The Telehealth FX clinical network serves patients across all 50 U.S. states and Washington D.C. Consultations are conducted online with board-certified physicians licensed in your specific state of residence.
Real Patient Reviews & Clinical Outcomes
"A1C dropped from 7.8% to 5.9% in 5 months. Telehealth FX handled the prescription smoothly and my physician checked in regularly throughout titration."
"Genuine Ozempic pens delivered with temperature monitoring. Lost 24 lbs while getting my blood sugars in optimal range."
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$1,199/mo flat rate across all doses. Save up to $100 on your first month order. Board-certified physician oversight. Free cold-chain delivery.
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