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In one of the first real-world studies, Tirzepatide shows impressive weight loss results for people without diabetes—shedding nearly 13% of body weight in just six months. Study: Real-world use and effectiveness of tirzepatide among people without evidence of type 2 diabetes in the United States . Image Credit: earthphotostock / Shutterstock In a recent study published in the journal Diabetes & Metabolism , scientists at Eli Lilly & Company and Carelon Research conducted a retrospective study to elucidate the treatment patterns and real-world effectiveness of Tirzepatide in promoting weight loss among US patients without a medical history of type 2 diabetes (T2D).
The study used data from the Healthcare Integrated Research Database (n = 4,177; female = 75.6%; mean age = 46.0 yrs) and evaluated the demographic and clinical characteristics of patients prescribed Tirzepatide interventions, their persistence with consuming the drug, and their weight outcomes.
Although most patients began on low doses of Tirzepatide, many did not reach higher target doses within six months, suggesting a cautious approach in real-world prescribing. Study findings revealed that most patients recommended Tirzepatide interventions suffered from one (73.8%) or more (51.
0%) obesity-related complications. While real-world Tirzepatide dose escalations were slower than those observed during the drug's clinical trials, with many patients remaining on lower doses such as 5 mg or 7.5 mg even after six months due to factors like off-label prescribing practices, supply constraints, or provider and patient preferences, patients who persisted with the medication for at least 6 months witnessed a mean weight reduction of 12.
9% among a subset of persistent, GLP-1 naive patients, not the entire cohort compared to baseline values. Notably, the persistence rate of 73.8% was higher than that previously reported for other GLP-1 receptor agonists, such as semaglutide and liraglutide.
These findings further suggest Tirzepatide's benefits in effectively promoting weight loss among overweight and obese individuals without T2D. Importantly, during the study period, Tirzepatide was prescribed off-label for weight management, as its FDA approval for obesity occurred only after the analyzed period. Background Obesity is a chronic disorder characterized by excessive body weight (body mass index [BMI] ≥ 30 kg/m2).
It is a medically serious condition associated with more than 200 comorbidities, such as cardiovascular diseases (CVDs), endocrine disorders, renal failure, metabolic syndrome, and central nervous system (CNS) diseases. Alarmingly, global obesity prevalence has been escalating at unprecedented levels, with an estimated 16% of all adults living with the condition in 2022, more than double that of 1990 estimates. Obesity prevalence is highest in developed and Western nations, with the United States of America (US) demonstrating one of the highest obesity prevalence rates globally – 42%.
Current projections expect this number to rise to 50% by 2030, substantially increasing economic and medical burdens on patients and their families. These facts highlight the need for effective weight management practices and clinical interventions to curb obesity. Present clinical interventions involve using obesity management medications (OMMs) in tandem with optimal health behaviors (good quality sleep and diet) to promote weight loss and prevent the development of further comorbidities.
Glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonists are the first line of treatment in this tandem approach. Tirzepatide is a novel dual GIP/GLP-1 receptor agonist recently approved for use as a medication to treat both type 2 diabetes (T2D) and excessive weight. While the drug demonstrated unprecedented efficacy and performance during its clinical trials (SURMOUNT-1), its real-world performance is yet to be validated.
"Weight reduction of ≥ 5% is the efficacy benchmark for OMMs, although achieving greater weight reduction of ≥ 10% or ≥ 15% may provide additional health benefits." About the study The present study is a retrospective analytical evaluation of the real-world effectiveness of Tirzepatide in routine clinical practice, focusing on patients who were prescribed the drug off-label exclusively for weight loss (and not T2D). It uses observational data from the Healthcare Integrated Research Database (HIRD), an administrative claims database of more than 80 million Americans across all US states.
Claims data was collected between May 13, 2022, and May 24, 2023, and included patient demographics (age, sex, race, geographic region), medical electronic health records (EHR), and outpatient pharmacy utilization. The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes were used to classify diseases (and comorbidities). Patients above the age of 18 years with at least 1 Tirzepatide claim and no medical history of T2D (defined as no diagnosis codes for T2D and HbA1c < 6.
5%) were included in subsequent analyses. The study evaluated patient persistence and Tirzepatide effectiveness (change in BMI over 6 months from the ‘index date’—the date of the first Tirzepatide pharmacy claim) on a per-obesity-class basis. Study findings Researchers noted that patients using Tirzepatide tended to be from higher socioeconomic backgrounds, raising questions about who can access and benefit from new treatments.
Patient data screening identified 4,177 patients meeting inclusion criteria, of which 780 patient profiles contained complete BMI data. Among these, a smaller subset of 200 patients with persistent Tirzepatide use and no prior GLP-1 use had complete weight data for outcome analysis. The mean age of the study cohort was 46.
0 years, with 75.6% female patients. A majority of patients were identified as non-Hispanic-White (72.
7%). Notably, 25.5% of patients demonstrated class 1 obesity (30-34.
9 kg/m2), 24.9% demonstrated class 2 obesity (35–39.9 kg/m2), and 31.
9% demonstrated class 3 obesity (≥ 40 kg/m2). Study findings revealed that an alarming 73.8% of patients suffered from at least one obesity-associated comorbidity, while 51.
0% had two or more obesity-related complications. Of these, dyslipidemia was found to be the most prevalent (37.0%), with hypertension (33.
5%) and anxiety (27.0%) following close behind. Tirzepatide utilization analyses revealed that 88.
6% of patients were initiated on 2.5 mg or 5 mg doses of the drug, and many did not escalate beyond these doses over 6 months, which is slower than titration patterns observed in clinical trials like SURMOUNT-1. A promising 73.
8% were persistent through the 6-month-long course. Encouragingly, in the subgroup of persistent, GLP-1 naive patients, a mean 12.9% weight reduction compared to baseline values was observed, highlighting the drug's effectiveness.
Conclusions The present study suggests the real-world performance of Tirzepatide as an effective clinical intervention against unwanted weight gain. While dose escalation was found to be slower than that observed during the drug's clinical trials (SURMOUNT-1), real-world persistence (73.8%) was higher than previously reported for other GLP-1 receptor agonists.
Furthermore, the efficacy (12.9% weight reduction) was comparable to its clinical performance in the specific analyzed subgroup. This highlights the benefits of Tirzepatide as an effective weight-loss intervention among overweight and obese American citizens.
However, as an observational study, the authors caution that results may be subject to limitations, including possible selection bias, higher socioeconomic status among the study population, and misclassification of undiagnosed T2D patients. Additionally, incomplete BMI and weight data may affect the generalizability of the results. Hankosky, E.
R., Desai, K., Chinthammit, C.
, Grabner, M., Stockbower, G., He, X.
, Mojdami, D., Wenziger, C., & Gibble, T.
H. (2025). Real-World Use and Effectiveness of Tirzepatide Among People Without Evidence of Type 2 Diabetes in the United States.
Diabetes & Metabolism , (p. 101636). Elsevier BV, DOI – 10.
1016/j.diabet.2025.
101636, https://www.sciencedirect.com/science/article/pii/S126236362500031X?via%3Dihub.
