Results from Phase 2 COURAGE Trial Demonstrating Potential to Improve Quality of GLP-1 receptor agonist-induced Weight Loss by Preserving Lean Mass, Presented at EASD
Regeneron Pharmaceuticals (NASDAQ: REGN) has presented complete 26-week results from its Phase 2 COURAGE trial at EASD, investigating combinations of semaglutide with trevogrumab for obesity treatment. The study demonstrated that adding trevogrumab could prevent approximately 50% of lean mass loss associated with semaglutide-induced weight loss.
Key findings show that while 33% of semaglutide-induced weight loss was from lean mass loss, the combination therapy achieved better body composition outcomes. The triplet combination (including garetosmab) showed the most significant results with only 7.4% lean mass loss and 92.6% fat mass loss. All treatment groups demonstrated numerical improvements in metabolic and lipid parameters.
The combinations were generally well-tolerated, though the triplet therapy group experienced higher discontinuation rates and two deaths occurred, which haven't been causally linked to the treatment.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha presentato i risultati completi di 26 settimane del suo studio di fase 2 COURAGE all'EASD, esaminando combinazioni di semaglutide con trevogrumab per il trattamento dell'obesità. lo studio ha mostrato che aggiungere trevogrumab potrebbe prevenire circa il 50% della perdita di massa magra associata alla perdita di peso indotta dal semaglutide.
I risultati chiave mostrano che, sebbene il 33% della perdita di peso indotta dal semaglutide provenisse da perdita di massa magra, la terapia combinata ha ottenuto migliori risultati nella composizione corporea. La tripla combinazione (incluso garetosmab) ha mostrato i risultati più significativi con solo 7,4% di perdita di massa magra e 92,6% di perdita di massa grassa. Tutti i gruppi di trattamento hanno mostrato miglioramenti numerici nei parametri metabolici e lipidici.
Le combinazioni sono state generalmente ben tollerate, anche se il gruppo triplo ha presentato tassi di interruzione più elevati e si sono verificati due decessi, non ancora attribuiti causalmente al trattamento.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha presentado resultados completos de 26 semanas de su ensayo de fase 2 COURAGE en la EASD, investigando combinaciones de semaglutida con trevogrumab para el tratamiento de la obesidad. El estudio demostró que añadir trevogrumab podría evitar aproximadamente el 50% de la pérdida de masa magra asociada a la pérdida de peso inducida por la semaglutida.
Los hallazgos clave muestran que, aunque el 33% de la pérdida de peso inducida por la semaglutida provino de pérdida de masa magra, la terapia combinada logró mejores resultados en la composición corporal. La triple combinación (incluido garetosmab) mostró los resultados más significativos con sólo el 7,4% de pérdida de masa magra y 92,6% de pérdida de masa grasa. Todos los grupos de tratamiento mostraron mejoras numéricas en parámetros metabólicos y lipídicos.
Las combinaciones, en general, fueron bien toleradas, aunque el grupo de tripleta experimentó tasas de descontinuación más altas y se produjeron dos muertes, que no se han vinculado causalmente al tratamiento.
Regeneron Pharmaceuticals (NASDAQ: REGN)은 EASD에서 비만 치료를 위한 세마글루타이드와 트레보그루맙의 조합에 대한 2상 COURAGE 시험의 26주 전체 결과를 발표했습니다. 연구는 트레보그루맙을 추가하면 세마글루타이드로 인한 체중 감소와 관련된 무지방 체중 손실의 약 50%를 예방할 수 있음을 보여주었습니다.
핵심 결과는 세마글루타이드로 인한 체중 감소의 33%가 무지방 체중 손실에서 비롯됐지만, 조합 치료가 체성분 측면에서 더 나은 결과를 얻었다는 것을 시사합니다. 가멸-가레토스맙을 포함한 트리플 조합은 6.7%가 아닌 7.4%의 무지방 체중 손실 및 92.6%的 지방량 손실로 가장 유의미한 결과를 보였습니다. 모든 치료군에서 대사 및 지질 매개변수에서 수치상의 개선이 나타났습니다.
대체로 내약성은 양호했으나 트리플 치료군은 중단률이 더 높았고 두 명의 사망이 발생했습니다. 이는 치료와 인과관계가 입증되지 않았습니다.
Regeneron Pharmaceuticals (NASDAQ: REGN) a présenté les résultats complets sur 26 semaines de son essai de phase 2 COURAGE lors de l’EASD, examinant des combinaisons de sémaglutide avec trevogrumab pour le traitement de l’obésité. L’étude a montré que l’ajout de trevogrumab pouvait prévenir environ 50 % de la perte de masse maigre associée à la perte de poids induite par le sémaglutide.
Les résultats clés montrent que, alors que 33 % de la perte de poids induite par le sémaglutide provenait d’une perte de masse maigre, la thérapie combinée a obtenu de meilleurs résultats en termes de composition corporelle. La triple combinaison (y compris le garetosmab) a montré les résultats les plus significatifs avec seulement 7,4 % de perte de masse maigre et 92,6 % de perte de masse grasse. Tous les groupes de traitement ont montré des améliorations numériques des paramètres métaboliques et lipidiques.
Les combinaisons ont été généralement bien tolérées, bien que le groupe triplet ait connu des taux d’interruption plus élevés et que deux décès soient survenus, qui n’ont pas été causalmment liés au traitement.
Regeneron Pharmaceuticals (NASDAQ: REGN) hat vollständige 26-wöchige Ergebnisse aus seiner Phase-2-COURAGE-Studie auf der EASD vorgestellt, die Kombinationen von Semaglutid mit Trevogrumab zur Behandlung von Fettleibigkeit untersucht. Die Studie zeigte, dass die Zugabe von Trevogrumab ungefähr 50% des Verlusts an fettfreier Masse verhindern könnte, der durch semaglutidinduzierten Gewichtsverlust entsteht.
Wichtige Ergebnisse zeigen, dass 33% des semaglutidinduzierten Gewichtsverlusts aus Fettfreier Masse stammen, die Kombinationstherapie jedoch bessere Ergebnisse in der Körperzusammensetzung erzielte. Die Dreifachkombination (einschließlich Garetosmab) zeigte die signifikantesten Ergebnisse mit nur 7,4% Verlust fettfreier Masse und 92,6% Fettmasseverlust. Alle Behandlungsgruppen zeigten numerische Verbesserungen bei metabolischen und Lipidparametern.
Die Kombinationen wurden im Allgemeinen gut vertragen, obwohl die Dreifachtherapie-Gruppe höhere Abbruchraten hatte und zwei Todesfälle auftraten, die bislang nicht kausal mit der Behandlung in Verbindung gebracht wurden.
Regeneron Pharmaceuticals (NASDAQ: REGN) قدمت نتائج كاملة لمدة 26 أسبوعاً من تجربة COURAGE المرحلة الثانية في EASD، تبحث عن تركيبات من سيماجلوتايد مع تريفوغروماب لعلاج السمنة. أظهرت الدراسة أن إضافة تريفوغروماب قد تمنع نحو 50% من فقدان كتلة الجسم الخالية من الدهون المرتبط بفقدان الوزن الناتج عن السيماجلوتايد.
تظهر النتائج الرئيسية أن 33% من فقدان الوزن الناتج عن السيماجلوتايد جاء من فقدان الكتلة الخالية من الدهون، بينما حققت العلاج المركب نتائج أفضل في تكوين الجسم. أظهرت التركيبة الثلاثية (بما في ذلك جراتوسماب) النتائج الأكثر أهمية مع فقدان كتلة جسد خالية من الدهون فقط بنسبة 7.4% وفقدان الدهون بنسبة 92.6%. جميع مجموعات العلاج أظهرت تحسنات عددية في المعايير الأيضية والدهون. كانت التركيبات عمومًا قابلة للتحمل جيداً، رغم أن مجموعة الثلاثية شهدت معدلات توقف أعلى ووقوع حالتي وفاة، التي لم تربط حتى الآن بالعلاج بشكل سببي.
Regeneron Pharmaceuticals（纳斯达克股票代码：REGN） 在 EASD 会议上公布了其二期 COURAGE 试验为期26周的完整结果，评估了< b>西马鲁肽与特雷沃格鲁单抗的组合治疗肥胖症的效果。研究显示，加入 特雷沃格鲁单抗 可以< b>大约防止与西马鲁肽诱导的体重下降相关的瘦体重损失约50%。
关键发现显示，尽管 33% 的西马鲁肽诱导的体重下降来自瘦体重损失，但联合治疗在体成分方面取得了更好的结果。三联组合（包括加雷托斯玛姆）显示出最显著的结果，仅有7.4%的瘦体重损失和92.6%的脂肪量损失。所有治疗组在代谢和血脂参数方面均有数值改善。总体而言，这些组合耐受性良好，尽管三联治疗组的中断率较高，并发生了两例死亡，目前尚未与治疗存在因果关系。
- Trevogrumab combination prevented about 50% of semaglutide-induced lean mass loss
- Triplet combination achieved 92.6% fat mass loss vs 67% with semaglutide alone
- Numerical improvements observed in metabolic parameters including blood pressure, cholesterol, and A1C
- Treatment combinations were generally well-tolerated with mostly mild to moderate adverse events
- Triplet combination showed higher discontinuation rates due to tolerability issues
- Two deaths occurred in the triplet therapy group, though not causally linked to treatment
- 33% of semaglutide-induced weight loss came from lean mass loss in the control group
Insights
Regeneron's COURAGE trial shows adding trevogrumab to semaglutide preserves muscle mass during weight loss, potentially improving GLP-1 therapy's profile.
The Phase 2 COURAGE trial has produced compelling data showing that combining trevogrumab with semaglutide can significantly improve body composition outcomes during weight loss. The trial revealed that 33% of weight loss from semaglutide alone comes from lean mass – essentially muscle – which is concerning given the importance of muscle for metabolic health and physical function. Adding trevogrumab, an anti-myostatin antibody, prevented approximately half of this lean mass loss, while the triplet combination (adding garetosmab) preserved even more.
The data shows clear dose-dependent effects, with the triplet combination resulting in only 7.4% of total weight loss coming from lean mass versus 33% with semaglutide alone. Importantly, the combinations not only preserved muscle but enhanced fat loss, with the triplet achieving
The safety profile appears generally manageable for the dual combinations, with mostly mild-to-moderate adverse events. However, the triplet combination showed higher discontinuation rates and two deaths occurred in this group, though causality hasn't been established. This raises important questions about the risk-benefit balance of the more aggressive triplet approach.
The numerical improvements in metabolic parameters (cholesterol, triglycerides, A1C) across all groups suggest these combinations maintain the beneficial metabolic effects of GLP-1 therapy. This 26-week data represents the weight-loss phase; patients are now in a weight-maintenance phase that will provide critical information on the durability of these effects through week 52.
Regeneron's trevogrumab data addresses a critical limitation of GLP-1 therapies, potentially creating significant competitive advantage in obesity market.
This data represents a potentially significant advance in the rapidly expanding GLP-1 weight loss market. Regeneron is targeting a key limitation of current GLP-1 therapies – the loss of lean muscle mass – which has been a growing concern among clinicians. By demonstrating that trevogrumab can preserve roughly half of the lean mass otherwise lost with semaglutide while enhancing fat loss, Regeneron is positioning itself to potentially differentiate in an increasingly crowded market.
The magnitude of effect is noteworthy: the triplet combination reduced the lean mass component of weight loss from
The market implications are substantial given the blockbuster status of GLP-1 therapies. However, the safety signals in the triplet arm raise important considerations about which combination might ultimately advance. The dual combination (higher-dose trevogrumab + semaglutide) may represent the optimal balance of efficacy and safety based on current data.
The trial design is also strategically important – the current weight-maintenance phase will determine if trevogrumab monotherapy can maintain these body composition benefits long-term. If successful, this could potentially lead to a sequential therapy approach (GLP-1 followed by trevogrumab) that might improve both outcomes and treatment economics.
These results support Regeneron's strategy to expand beyond its traditional focus areas into metabolic disease, where it can leverage its antibody expertise to enhance existing therapies rather than directly competing with established GLP-1 players.
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss
Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups
TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated analyses from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. The complete 26-week results were consistent with interim data previously reported, demonstrating that the addition of trevogrumab with or without garetosmab could significantly reduce the loss of lean mass associated with semaglutide-induced weight loss; the results confirmed that
"These complete 26-week COURAGE results demonstrate a meaningful opportunity to preserve muscle mass while enhancing fat loss," said Julio Rosenstock, M.D., Lead PI and Senior Scientific Advisor Velocity Clinical Research at Medical City and Clinical Professor of Medicine, University of Texas Southwestern Medical Center, Dallas. “These encouraging early data, with positive trends in lipid parameters, warrant further studies to confirm the potential of trevogrumab’s role in preserving lean muscle mass during weight loss, especially in combination with incretin-related therapies.”
COURAGE was designed to investigate the quality of weight loss in patients with obesity (BMI ³30 kg/m2). Treatment is divided into two 26-week periods comprised of a weight-loss phase and a weight-maintenance phase. The three primary efficacy endpoints were assessed in this analysis at week 26 (end of weight-loss phase), and included percent change from baseline at week 26 in lean mass, fat mass and body weight. During the weight-loss phase, patients were randomized to receive semaglutide 2.4 mg alone or in combination with trevogrumab 200 mg (lower dose), trevogrumab 400 mg (higher dose) or higher-dose trevogrumab plus garetosmab 10 mg/kg (triplet).
At this analysis,
| Semaglutide monotherapy (n=151) | Lower-dose combo (n=149) | Higher-dose combo (n=152) | Triplet (n=147) | |
| Lean mass | ||||
| Percent change from baseline (SE) | -6.5 (0.5) | -3.3 (0.5) | -3.8 (0.5) | -2.0 (0.6) |
| Change in kg from baseline (% of total weight loss) | -3.3 kg ( | -1.5 kg*** ( | -1.9 kg*** ( | -0.9 kg*** ( |
| Fat mass | ||||
| Percent change from baseline (SE) | -15.7 (0.9) | -17.3 (0.9) | -19.1 (0.9) | -27.1 (1.1) |
| Change in kg from baseline (% of total weight loss) | -6.7 kg ( | -7.6 kg ( | -8.5 kg* ( | -11.8 kg*** ( |
| Body weight | ||||
| Percent change from baseline (SE) | -10.6 (0.5) | -9.9 (0.5) | -11.1 (0.5) | -13.4*** (0.6) |
SE= Standard Error
NOTE: Lean mass and fat mass was calculated using dual-energy X-ray absorptiometry (DXA) scan, while body weight was measured using a scale; as a result, the lean and fat mass numbers may not exactly sum to body weight. Total weight loss is defined as the sum of lean mass loss and fat mass loss. Results are based on least-squares means derived from MMRM analysis using efficacy estimand that excludes data after the treatment discontinuation.
***p<0.001; *p<0.05; p-values are for the primary endpoints of % change from baseline at week 26 in each category, and were not corrected for multiplicity.
Numerical improvements in metabolic and lipid parameters, secondary and exploratory endpoints, were seen across all treatment groups, including improvements in waist circumference, blood pressure, cholesterol, triglycerides and A1C.
The combination of semaglutide with trevogrumab was generally well-tolerated; Adverse events that occurred in ≥
As previously reported, the triplet combination of semaglutide with both antibodies had a substantially higher rate of discontinuations due to tolerability issues and other adverse events. Two deaths occurred in the triplet group, one due to an undetermined cause in a patient with multiple cardiovascular risk factors and the second due to a cardiac arrest in a person with a history of cardiovascular disease. Regeneron has not identified a causal association between treatment and these events.
After 26 weeks, patients enter into the weight-maintenance phase in which they receive either higher-dose trevogrumab monotherapy or placebo through the end of the trial (week 52).
The safety and efficacy of trevogrumab and garetosmab have not been evaluated by any regulatory authority.
About Regeneron in Obesity
Obesity is a complex, multifaceted disease and a growing public health concern that affects more than a billion people worldwide. Despite the revolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the quality of this weight loss can be negatively impacted because these agents can cause profound muscle loss. Moreover, a high percentage of patients cycle on and off treatment – while off treatment they can regain almost all of the weight lost, but mostly in the form of fat, leaving them with negatively altered body composition.
At Regeneron, we are developing a pipeline focused on the quality of weight reduction. We have several independent approaches focused on promoting and preserving muscle during weight loss, so as to increase the amount of fat loss since adiposity is the principal driver of comorbidities and metabolic diseases associated with obesity. In addition, Regeneron has an extensive pipeline of agents to address some of these co-morbidities and metabolic diseases, which have the potential to be combined with GLP-1RAs. The combination of our science, pipeline, research and clinical innovation uniquely positions us to make a meaningful difference in obesity and obesity-related diseases.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
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FAQ
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