Semaglutide (GLP-1) Clinical Trials
STEP Program — Phase 3 Clinical Trials
- Wilding JPH et al. "Once-Weekly Semaglutide in Adults with Overweight or Obesity." New England Journal of Medicine. 2021;384:989–1002. (STEP-1) — Primary source for 14.9% average weight loss figure in adults with obesity without type 2 diabetes.
- Davies M et al. "Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes." The Lancet. 2021;397(10278):971–984. (STEP-2) — Source for semaglutide outcomes in type 2 diabetes population (9.6% average weight loss).
- Wadden TA et al. "Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity." JAMA. 2021;325(14):1403–1413. (STEP-3) — Source for 16% average weight loss with behavioral therapy addition.
- Ryan DH et al. "Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity." NEJM. 2023. (SELECT) — Cardiovascular risk reduction with semaglutide.
Tirzepatide (GLP-1/GIP) Clinical Trials
SURMOUNT Program — Phase 3 Clinical Trials
- Jastreboff AM et al. "Tirzepatide Once Weekly for the Treatment of Obesity." New England Journal of Medicine. 2022;387:205–216. (SURMOUNT-1) — Primary source for 22.5% average body weight loss at 15mg dose over 72 weeks.
- Garvey WT et al. "Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes." The Lancet. 2023;402(10402):583–594. (SURMOUNT-2) — Tirzepatide outcomes in type 2 diabetes population (15.7% average weight loss).
Comparative Evidence
- Lincoff AM et al. "Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes." NEJM. 2023. SELECT trial cardiovascular outcomes.
- Comparison of tirzepatide vs semaglutide real-world outcomes. JAMA Internal Medicine. 2023. — Source for tirzepatide superiority across all BMI categories over 12 months.
B12 and B6 Supplementation References
- Practical guidance on B12 monitoring during GLP-1 therapy — multiple clinical practice publications noting B12 absorption risk during significant caloric restriction.
- Role of Pyridoxine (B6) in protein metabolism and energy production — standard nutritional biochemistry references.
Regulatory References
- FDA Drug Shortages Database — semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) shortage designations (2022–2025).
- FDA Compounding Laws and Regulations — 503A (traditional compounding) and 503B (outsourcing facility) framework. 21 U.S.C. § 503A.
- FDA Warning Letter to NewSelf Limited LLC — February 2026. Document available via FDA's warning letter database. See our full explainer.
- AllyRx editorial review of NewSelf — September 2026. Independent editorial scoring (68/100) and user review compilation (2.7/5, 12 reviews).
- Factually.co — "NewSelf Reviews: Is NewSelf Legit?" April 2026. Multi-source aggregated analysis.
Disclaimer on Source Use
Clinical trial results cited represent population-level averages under controlled study conditions with medical supervision. Individual results on NewSelf's compounded GLP-1 program will vary based on adherence, diet, physical activity, starting weight, metabolic factors, prescribed dose, and clinical monitoring. These figures are not guarantees of individual outcome. See our medical disclaimer.