Tirzepatide news and clinical trials

LMC Diabetes & Endocrinology Ltd. registered an observational study to evaluate the effectiveness of switching from injectable semaglutide to tirzepatide in 650 adults living with type 2 diabetes and obesity.

Hoffmann-La Roche registered a phase 3 randomized clinical trial to evaluate the safety and efficacy of enicepatide compared to tirzepatide in 948 participants with type 2 diabetes who have inadequate glycemic control on oral medications.

A compounder issued a recall for a copycat version of Zepbound following concerns about the safety of such knockoff weight loss drugs.

Eli Lilly and Company registered a Phase 3 trial to investigate the safety and efficacy of eloralintide and tirzepatide coformulation compared with tirzepatide, eloralintide, and placebo in 2115 adults with obesity.

Eli Lilly and Company registered a Phase 3 study to evaluate the efficacy and safety of eloralintide and tirzepatide coformulation compared to tirzepatide in 1000 adults with obesity or overweight and type 2 diabetes.

M.D. Anderson Cancer Center registered a phase 2 feasibility trial to study the use of tirzepatide for preventing overweight and obesity-associated cardiotoxicity in 30 adolescent and young adult cancer survivors. The study focuses on those who have completed chemotherapy.

Carolina Infusion, LLC initiated a class II recall of various semaglutide and semaglutide/cyanocobalamin injectables. The firm cited a lack of assurance of sterility related to the use of bacteriostatic water and processing equipment.

Apothecary Pharma LLC initiated a nationwide Class II recall of Apothecary NAD+ Injection 200 mg/mL, 6 mL sterile multi-dose vials. The recall was issued due to a lack of assurance of sterility.

New systematic review in BMJ medicine: Values, preferences, and treatment burden for initiation of GLP-1 receptor agonists, SGLT-2 inhibitors, tirzepatide, and finerenone in adults with type 2 diabetes: systematic review.

Novo Nordisk A/S registered a phase 1 study to assess the tolerability of switching 60 participants with overweight, obesity, or type 2 diabetes from their current maintenance dose of tirzepatide to a new treatment called zenagamtide.

The National Medical Research Center for Therapy and Preventive Medicine began a study comparing the effectiveness of tirzepatide and transcutaneous auricular vagus nerve stimulation in 120 adults with class I obesity.

Istanbul Saglik Bilimleri University registered a prospective descriptive study of 42 participants to assess the relationship between GLP-1 receptor agonist use and sarcopenia in non-diabetic individuals with obesity. Researchers will evaluate body composition changes over 3 months.

Boehringer Ingelheim registered a phase 3 trial to evaluate initiation strategies for survodutide, including new use or switching from semaglutide or tirzepatide, in 350 adults with obesity but no diabetes. The study aims to determine if survodutide helps these participants lose weight.

Pfizer registered a Phase 3 trial to evaluate the safety and effectiveness of switching to monthly berobenatide in 660 adults who have already lost weight while taking weekly semaglutide or tirzepatide. The study excludes people with diabetes and spans about 11 months.

The Woolcock Institute of Medical Research registered a phase 2/3 comparative trial of 256 participants to test if weight loss pharmacotherapy with tirzepatide is superior to continuous positive airway pressure for treating obstructive sleep apnea.

Nanjing First Hospital registered an observational study to analyze dynamic changes in gut microbiota and metabolic profiles in 80 obese patients receiving tirzepatide. The research will also investigate the recovery pattern of gastric emptying after drug withdrawal.

Ascletis Pharma (China) Co., Limited registered a phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a monthly ASC35 injection compared to tirzepatide in 84 adults with obesity or overweight.

Zagazig University registered a completed phase 3 trial that evaluated the efficacy of weekly dulaglutide, semaglutide, and tirzepatide in 150 non-diabetic obese adults by tracking changes in weight, BMI, and metabolic markers.

Universidade do Porto registered a phase 3 trial to determine if weekly tirzepatide helps 70 patients achieve further weight loss after experiencing suboptimal results from previous bariatric surgery.

The University of Texas Southwestern Medical Center registered a phase 2 trial to evaluate the tolerability, safety, and efficacy of tirzepatide for treating moderate or severe methamphetamine use disorder in 228 participants.

Zagazig University registered a phase 3 study comparing the effects of dulaglutide, semaglutide, and tirzepatide on metabolic factors like insulin sensitivity and lipid profiles in 159 diabetic and non-diabetic obese patients.

Eli Lilly and Company completed a phase 2 study investigating the safety and efficacy of LY3841136 and tirzepatide, alone or in combination, for weight management in 367 adults with obesity or overweight and type 2 diabetes.

Eli Lilly and Company registered a phase 3 trial to evaluate the efficacy, safety, and pharmacokinetics of weekly tirzepatide compared to a placebo in 150 pediatric participants aged 6 to less than 12 years with obesity.

Milton S. Hershey Medical Center registered a pilot study of 15 patients to evaluate the safety and preliminary efficacy of combining once-weekly tirzepatide with a levonorgestrel intrauterine device for endometrial cancer or neoplasia.

Universiti Sains Malaysia registered an observational study to evaluate the real-world outcomes of tirzepatide in 330 Pakistani adults with obesity, prediabetes, or type 2 diabetes over 24 weeks.

Researchers published a meta-analysis of 10 randomized controlled trials including 6515 individuals regarding tirzepatide use. The study concluded that tirzepatide was not associated with atrial fibrillation or atrial arrhythmia.

New review in Endocrinology, diabetes & metabolism: Efficacy and Safety of Tirzepatide Versus Dulaglutide in Type 2 Diabetes With or Without Established Atherosclerotic Cardiovascular Disease: A Network Meta-Analysis of Randomized Clinical Trials.

Eli Lilly and Company registered a phase 1 study with 18 participants to investigate how tirzepatide affects gastric emptying in adults with type 1 diabetes and overweight or obesity.

CSPC Ouyi Pharmaceutical Co., Ltd. registered a Phase 2 trial of 240 participants to evaluate the safety and efficacy of SYH2069 injection compared to placebo and 15mg tirzepatide in patients with Type 2 Diabetes.

A systematic review and meta-analysis of 10 studies including 41 381 participants found that tirzepatide was associated with greater weight reduction and better HbA1c control than semaglutide. Tirzepatide was also associated with a higher risk of serious adverse events.

A meta-analysis of 1776 participants found that weight regain is rapid after discontinuing semaglutide or tirzepatide, with an average regain of 1.04 kg/month. Patients were projected to return to their baseline weight within 15.00 months.

Researchers conducted a post hoc analysis of two phase 3 trials evaluating tirzepatide in participants with moderate-to-severe obstructive sleep apnea and obesity. They found that tirzepatide treatment was associated with improvements in sleep apnea outcomes regardless of baseline characteristics.

The FDA approved an efficacy supplement for the medication Mounjaro, which contains the active ingredient tirzepatide, on August 27, 2026.

Researchers conducted a systematic review to determine if specific days of the week are better for semaglutide or tirzepatide administration. The study found no comparative data on day-of-week effects, concluding that flexible dosing schedules are best for adherence.

The FDA approved an efficacy supplement for the diabetes and weight management medication Zepbound, which contains the active ingredient tirzepatide, on August 26, 2026.

The University of Chicago registered a phase 1 trial of 30 non-small cell lung cancer patients to determine if tirzepatide can mitigate weight gain and metabolic side effects associated with lorlatinib treatment.

The Technical University of Munich registered a phase 4 trial to examine whether resistance training can prevent the loss of thigh muscle volume in 150 adults with obesity who are receiving tirzepatide treatment.

Researchers meta-analyzed 32 randomized controlled trials with 47,332 participants assessing blood pressure adverse events. Tirzepatide reduced hypertension risk but increased hypotension risk, while semaglutide showed a neutral safety profile regarding blood pressure.

A post hoc analysis of the SURMOUNT clinical trials found that a significantly higher proportion of participants treated with tirzepatide achieved a triple endpoint of body weight reduction, improved systolic blood pressure, and lower non-HDL cholesterol compared to those receiving a placebo.

The University of North Carolina, Chapel Hill registered a trial of 20 participants to determine if tirzepatide reduces chronic high bowel frequency in patients with an ileal pouch-anal anastomosis better than standard anti-diarrheal therapy.

New systematic review in Journal of endocrinological investigation: Analysis of the efficacy and safety of liraglutide, semaglutide, and tirzepatide for the treatment of overweight and obesity: a systematic review and network meta-analysis.

The Cleveland Clinic registered a trial of 30 participants to assess the effects of tirzepatide on lung function, skeletal muscle health, and inflammation in overweight or obese adults with chronic obstructive pulmonary disease.

Shahid Beheshti University of Medical Sciences registered a randomized controlled trial of 60 participants to evaluate if tirzepatide improves physical function, symptoms, and quality of life in adults with obesity and reduced ejection fraction heart failure.

Texas Tech University registered a study of 27 participants to compare how GLP-1 receptor agonist therapy versus a structured lifestyle intervention affects heart and metabolic health markers.

Eli Lilly and Company completed a Phase 2 study of 134 participants assessing how tirzepatide affects kidney function and kidney hypoxia in people with obesity and chronic kidney disease.

The FDA announced the availability of additional revised draft product-specific guidances. These documents provide recommendations for industry on designing bioequivalence studies to support abbreviated new drug applications.

A meta-analysis of five phase 3 SURMOUNT trials found that tirzepatide produced similar relative percentage weight loss in both Asian and non-Asian adults without diabetes. While non-Asians showed greater absolute weight loss, this reflected higher baseline body weight.

Researchers published a meta-analysis of 22 trials with 29,023 participants assessing tirzepatide's effect on cardiovascular outcomes. The study found that tirzepatide was associated with a significant reduction in major adverse cardiovascular events and all-cause mortality.

A subpopulation analysis of the SURMOUNT-5 trial found that tirzepatide led to greater weight loss (-20.1%) than semaglutide (-12.9%) in 383 participants with obesity disease after 72 weeks of treatment.

New meta-analysis in Diabetes, obesity & metabolism: Cardiovascular Outcomes With Tirzepatide Versus GLP-1 Receptor Agonists in Overweight or Obesity: A Systematic Review and Meta-Analysis.

The FDA is extending the comment period for a notice concerning the 503B Bulks List of drug substances. This follows the agency's proposal not to include semaglutide, tirzepatide, or liraglutide on the list of bulk drug substances allowed for use in compounding.

Researchers performed a post hoc analysis of the SURMOUNT-1 and SURMOUNT-2 trials involving 2384 participants to evaluate weight response. They found that early responders at week 8 experienced greater weight loss and improvements in cardiometabolic risk parameters compared to non-early responders.

The phase 3 SURPASS-CN-MONO trial in China found that 40 weeks of tirzepatide monotherapy significantly reduced HbA1c and body weight compared to placebo in adults with early type 2 diabetes. No cases of clinically significant or severe hypoglycemia occurred during the study.

A post hoc analysis of the SURMOUNT-J trial found that treatment with 10 mg or 15 mg of tirzepatide significantly reduced predicted 10-year cardiovascular disease risk in Japanese adults with obesity, with mean absolute reductions of 2.8% and 2.5% respectively.

The phase 2 EMBRAZE study of 102 adults with overweight or obesity found that adding apitegromab to tirzepatide therapy preserved lean mass more effectively than tirzepatide combined with placebo over 24 weeks. Participants receiving apitegromab lost 1.9 kg less lean mass.

A post hoc analysis of the SURMOUNT-1 trial found that tirzepatide treatment for 72 weeks led to significant changes in various cardiovascular risk biomarkers compared to placebo. These improvements included reductions in inflammation, metabolic stress, and endothelial dysfunction markers.

New randomized trial in Diabetes, obesity & metabolism: Short-Term Combined Treatment With Tirzepatide and Metformin for Overweight/Obese Chinese Women With Polycystic Ovary Syndrome: A Prospective, Open-Label, Randomised Controlled Trial.

New paper in Endocrinology, diabetes & metabolism: Comparative Effectiveness of CagriSegma, Semaglutide, Cagrilintide and Tirzepatide in the Management of Overweight and Obesity: A Network Meta-Analysis of Randomized Clinical Trials.

The SURPASS-EARLY trial of adults with early type 2 diabetes found that 2 years of tirzepatide treatment was superior to intensified conventional care in reducing HbA1c, body weight, and waist circumference. A higher percentage of tirzepatide users achieved normoglycemia.

Researchers published the results of a phase 3b trial involving 274 adults with psoriasis and obesity. They found that 27.1% of participants receiving ixekizumab plus tirzepatide simultaneously achieved clear skin and 10% weight loss, compared to 5.8% in the ixekizumab group.

Researchers published results from a 112-week phase 3b trial of 441 patients examining tirzepatide for weight maintenance in adults with obesity. The study assessed the efficacy of continuing tirzepatide at its maximum tolerated dose compared to reducing the dose or switching to a placebo.

Researchers published an exploratory analysis of the SURPASS-CVOT trial comparing tirzepatide and dulaglutide for kidney events in 13 299 patients with type 2 diabetes. The provided text does not report the final findings regarding the primary kidney outcome.

The phase 3 SURMOUNT-J trial showed that tirzepatide treatment for 72 weeks significantly improved physical and psychosocial health-related quality of life in Japanese adults with obesity compared to placebo. Improved quality of life scores correlated with weight loss across treatment groups.

A narrative review of clinical trials concluded that while tirzepatide shows superior metabolic efficacy in direct comparative trials regarding weight and HbA1c, semaglutide currently possesses more robust evidence for cardiovascular risk reduction.

Researchers performed a post-hoc analysis of 2,538 participants from the SURMOUNT-1 trial to evaluate changes in waist-to-height ratio categories after tirzepatide treatment. Tirzepatide was associated with sustained improvements in waist-to-height ratios compared to placebo over 72 weeks.

The FDA announced it is proposing not to include semaglutide, tirzepatide, and liraglutide on the list of bulk drug substances for which there is a clinical need for outsourcing facilities to use in compounding. The agency is currently evaluating substances nominated for this list.

Researchers published a network meta-analysis in Diabetes, obesity & metabolism comparing injectable tirzepatide to oral semaglutide, finding that tirzepatide 10 and 15 mg were associated with statistically significantly greater reductions in weight and waist circumference.

A study using data from the SURMOUNT-5 trial evaluated the cost-effectiveness of tirzepatide versus semaglutide in adults with obesity or overweight. The model estimated that tirzepatide was less costly and more efficacious than semaglutide, with per patient cost savings of $41,688.

New Life Pharma LLC initiated a voluntary recall of 2 vials of Semaglutide injection. The reason for the recall is a lack of assurance of sterility.

The FDA approved an efficacy supplement for the medication Mounjaro, which contains the active ingredient tirzepatide, on December 19, 2025.

The FDA announced the availability of new and revised draft product-specific guidances. These guidances offer industry recommendations on the design of bioequivalence studies for abbreviated new drug applications.

The FDA announced the availability of new and revised draft product-specific guidances. These documents provide recommendations on the design of bioequivalence studies to support abbreviated new drug applications.

ProRx LLC initiated a voluntary recall of 8,400 vials of Semaglutide injection due to a lack of assurance of sterility.