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The DREAMS-3 trial is a randomized, open-label Phase 3 study designed to compare the efficacy and safety of mazdutide (a glucagon receptor/GLP-1 receptor co-agonist) versus semaglutide (a GLP-1 receptor agonist) in Chinese adults with type 2 diabetes (T2D) and obesity. This publication reports the trial's rationale, design, and baseline characteristics rather than outcome results, as the study is ongoing with an expected completion date in early 2026. A total of 349 participants (mean age 42.4 years; 44.7% male) were randomized 1:1 to either treatment arm for a 32-week active-controlled period followed by a 24-week extension. At baseline, participants had a mean HbA1c of 8.0%, body weight of 90.5 kg, and BMI of 33.0 kg/m². The mean T2D duration was 1.8 years, and approximately 39.5% were on metformin. The primary endpoint is the proportion of participants achieving HbA1c targets. Notably, comorbidities such as metabolic-associated fatty liver disease and gout/hyperuricemia showed strong associations with BMI. As a design and baseline data paper, no efficacy or safety outcomes are yet available, limiting current evidence value.
Contemporary clinical trials · Nov 2025DOI ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (recruiting). This is a 28-week, single-arm, open-label phase II clinical trial evaluating the combination of Tirzepatide and remote, supervised, tailored resistance exercise training to achieve weight loss in adult survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. Primary Objective(s): • To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise (three sessions per week) in adult survivors of chi
ClinicalTrials.gov · Nov 2025View trial ↗ Insufficient
SYNCHRONIZE™-2 is an ongoing double-blind, randomized, placebo-controlled Phase 3 trial evaluating survodutide — an investigational dual glucagon receptor/GLP-1 receptor agonist — for weight reduction in adults with obesity and type 2 diabetes (T2D). This paper reports only the baseline characteristics of the 752 enrolled participants across 133 sites in 19 countries; efficacy and safety results are not yet available. Participants were randomized 1:1:1 to one of two doses of weekly subcutaneous survodutide or placebo, alongside diet and physical activity guidance. At baseline, the cohort had a mean age of 55.7 years, mean BMI of 36.5 kg/m², mean body weight of 104.1 kg, and mean HbA1c of 7.4%; roughly half were female. Common comorbidities included hypertension (69%), dyslipidaemia (68%), and obstructive sleep apnoea (17%). The geographic distribution included participants from Europe, North America, and East Asia, suggesting reasonable diversity. Primary endpoints are percentage change in body weight and achievement of ≥5% weight loss at Week 76. A key limitation of this publication is that it presents only baseline data — no outcomes are yet reported — so no conclusions about efficacy or safety of survodutide can be drawn from this paper alone.
Diabetes, obesity & metabolism · Nov 2025DOI ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (recruiting). The purpose of this study is to investigate how the duration of fasting and temporary stopping of Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach in people using liraglutide (injected), semaglutide (taken by mouth) or semaglutide (injected). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are already using.
ClinicalTrials.gov · Nov 2025View trial ↗ Insufficient
This paper presents a hypothesis-generating perspective piece examining the potential interaction between amylin-based therapies — including the pramlintide and cagrilintide receptor agonists, and the combination therapy CagriSema — and the renin-angiotensin system (RAS). The authors hypothesize that amylin receptor agonists may activate the RAS, which could potentially counteract the cardiorenal benefits of these obesity and type 2 diabetes treatments. However, they note the paradox that CagriSema demonstrated meaningful blood pressure reductions in phase 3 trials. The authors further hypothesize that concurrent use of RAS inhibitors (ACE inhibitors or angiotensin-receptor blockers) may redirect amylin-induced RAS activation toward the protective "alternative RAS pathway," promoting vasodilatory, anti-inflammatory, and antiproliferative effects via Mas receptors. To test these hypotheses, the authors propose a research agenda encompassing preclinical studies, post-hoc trial analyses stratified by RAS inhibitor use, biomarker studies, and prospective mechanistic human studies. No original experimental data are presented. Key limitations include the entirely speculative nature of the central claims, the absence of direct supporting evidence, and reliance on inference from existing trial-level observations.
Lancet (London, England) · Nov 2025DOI ↗ Insufficient
This paper reports the baseline characteristics of participants enrolled in SYNCHRONIZE-1, a multinational, randomized, double-blind, placebo-controlled Phase 3 trial evaluating survodutide — a dual glucagon receptor and GLP-1 receptor agonist — for weight management in adults with obesity but without type 2 diabetes. A total of 725 participants from 14 countries were randomized 1:1:1 to receive once-weekly subcutaneous injections of survodutide (up-titrated to 3.6 mg or 6.0 mg) or placebo over 76 weeks. At baseline, participants had a mean age of 47.1 years, mean BMI of 37.9 kg/m², and mean waist circumference of 115.2 cm; 59.4% were female. Common obesity-related complications included hypertension (40.0%), dyslipidaemia (33.7%), and prediabetes (30.2%). The primary endpoints are percent body weight change and achievement of ≥5% body weight reduction from baseline to Week 76. As this publication covers only baseline data, no efficacy or safety outcomes are yet reported. The study's key limitation at this stage is that it describes enrollment characteristics only, with no outcome data available.
Diabetes, obesity & metabolism · Nov 2025DOI ↗ 🧪 TrialInsufficient
Registered Phase 4 interventional trial (recruiting). The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
ClinicalTrials.gov · Oct 2025View trial ↗ Insufficient
This study focused on the development and validation of an analytical detection method — not a clinical intervention — for identifying growth hormone-releasing hormone (GHRH) and its synthetic analogs (sermorelin/CJC-1293, tesamorelin, and CJC-1295) in human urine samples for anti-doping purposes. These peptides are banned by the World Anti-Doping Agency (WADA) due to their potential performance-enhancing effects. The researchers developed a nano liquid chromatography coupled with quadrupole/orbitrap mass spectrometry (nano-LC-Q/Orbitrap MS) approach, systematically optimizing sample preparation steps including solid-phase extraction (SPE) and ultrafiltration. The finalized workflow — ultrafiltration followed by SPE — was fully validated per WADA guidelines, assessing selectivity, reliability, limits of detection (LOD ≤ 0.5 ng/mL), limits of identification (LOI 0.5–0.75 ng/mL), carryover, robustness, autosampler stability, and matrix effects. The method demonstrated sufficient sensitivity for both screening and confirmation of target peptides in urine. A key limitation is that this is a purely analytical/methodological study; it provides no clinical, pharmacological, or physiological data about the effects of these peptides in humans, and its findings are confined to laboratory detection performance.
Journal of pharmaceutical and biomedical analysis · Oct 2025DOI ↗ Insufficient
This paper is a published correspondence ("Reply") in the journal Pharmaceuticals, in which the original authors of a literature and patent review on the BPC 157 peptide respond to a commentary submitted by Sikiric et al. The reply addresses points raised in the comment regarding BPC 157's proposed mechanisms of action, specifically its purported roles in modulating angiogenesis and nitric oxide (NO) pathways. The responders engage with the argument that BPC 157 may selectively target the cytotoxic and damaging aspects of NO signaling while preserving or restoring its essential protective physiological functions. As a correspondence piece reacting to a comment on a review article, this paper does not present new experimental data, clinical trials, or original preclinical findings. Its contribution is interpretive and editorial in nature, clarifying the scope and conclusions of the original review in light of the mechanistic claims put forth by the commentators. Limitations include the absence of any new empirical evidence; all mechanistic claims discussed are derived from previously published literature cited by both parties.
Pharmaceuticals (Basel, Switzerland) · Sep 2025DOI ↗ 🧪 TrialInsufficient
Registered observational trial (terminated). This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
ClinicalTrials.gov · Sep 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (recruiting). The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll abo
ClinicalTrials.gov · Sep 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (recruiting). This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin which can help lower blood sugar levels and delay gastric emptying. The recent FDA approval of GLP-1RAs has changed the landscape for pharmacothe
ClinicalTrials.gov · Aug 2025View trial ↗ 🧪 TrialInsufficient
Registered observational trial (enrolling by invitation). This observational study will explore how Wegovy® (Semaglutide) is used in everyday situations, how it might affect things like weight, body mass index (BMI) and waist circumference, and what kind of impact it could have on overall quality of life. The overall purpose of this study is to understand how Wegovy impacts weight when used as part of regular medical care. Participants will be treated with Wegovy as prescribed to the participant by their doctor, in accordance with normal clinical practice. The study will last for about two yea
ClinicalTrials.gov · Jul 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (recruiting). Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: To test Tirzepatide in people with AUD and MetALD. Eligibility: People aged 21 years and older with AUD and MetALD. Design: Participants will be screened. They will have a physical
ClinicalTrials.gov · Jul 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (recruiting). The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.
ClinicalTrials.gov · Jun 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (recruiting). The primary objective of Study GZQG is to compare the effect of retatrutide and placebo on total clamp disposition index (cDI) after 28 weeks of treatment.
ClinicalTrials.gov · May 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 4 interventional trial (not yet recruiting). The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive HBLT needed or could low in
ClinicalTrials.gov · May 2025View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (recruiting). The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the eff
ClinicalTrials.gov · May 2025View trial ↗ Insufficient
This paper presents the protocol for PANDA II, a multicenter randomized controlled trial investigating whether thymosin alpha 1 (Tα1) supplementation can prevent organ dysfunction following acute type A aortic dissection (ATAAD) surgical repair. A total of 330 patients will be equally randomized to receive either Tα1 plus standard care or placebo plus standard care. The primary endpoint is the difference in mean postoperative Sequential Organ Failure Assessment (SOFA) scores measured daily through postoperative day 7. The scientific rationale centers on Tα1's proposed ability to rebalance post-operative immune dysregulation, thereby reducing systemic inflammatory response syndrome (SIRS)-mediated organ injury. As a protocol paper, no efficacy or outcome data are yet available. Limitations inherent to this stage include the absence of results, potential challenges in blinding given Tα1's immunological activity, and the complexity of standardizing post-surgical care across multiple centers. The trial is registered on ClinicalTrials.gov (NCT05339529). Findings will be published once the trial is completed, and this protocol represents a foundational step toward establishing evidence for Tα1 as a novel therapeutic strategy in this high-risk surgical population.
Future cardiology · May 2025DOI ↗ 🧪 TrialInsufficient
Registered Phase 3 interventional trial (recruiting). The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.
ClinicalTrials.gov · Apr 2025View trial ↗