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* Diabetes, Obesity and Metabolism
Diabetes, Obesity and Metabolism
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RESEARCH LETTER
Open Access
SURVODUTIDE, A GLUCAGON RECEPTOR/GLUCAGON-LIKE PEPTIDE-1 RECEPTOR DUAL AGONIST,
IMPROVES BLOOD PRESSURE IN ADULTS WITH OBESITY: A POST HOC ANALYSIS FROM A
RANDOMIZED, PLACEBO-CONTROLLED, DOSE-FINDING, PHASE 2 TRIAL
Carel W. le Roux PhD,
Carel W. le Roux PhD
* orcid.org/0000-0001-5521-5445
St. Vincent's University Hospital and University College Dublin, Dublin, Ireland
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Oren Steen MD,
Oren Steen MD
Private practice, Toronto, Ontario, Canada
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Kathryn J. Lucas MD,
Kathryn J. Lucas MD
Diabetes and Endocrinology Consultants, Morehead City, North Carolina, USA
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Elif I. Ekinci PhD,
Elif I. Ekinci PhD
* orcid.org/0000-0003-2372-395X
Austin Health, Heidelberg, Victoria, Australia
The Australian Centre for Accelerating Diabetes Innovation, University of
Melbourne, Parkville, Victoria, Australia
Department of Medicine, Melbourne Medical School, University of Melbourne,
Melbourne, Victoria, Australia
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Elena Startseva MD,
Elena Startseva MD
Boehringer Ingelheim International GmbH, Ingelheim, Germany
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Anna Unseld MSc,
Anna Unseld MSc
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
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Samina Ajaz Hussain MD,
Samina Ajaz Hussain MD
Boehringer Ingelheim International GmbH, Ingelheim, Germany
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Anita M. Hennige MD,
Corresponding Author
Anita M. Hennige MD
* anita.hennige@boehringer-ingelheim.com
* orcid.org/0000-0002-5149-4966
Boehringer Ingelheim International GmbH, Biberach, Germany
Correspondence
Anita M. Hennige, Boehringer Ingelheim International GmbH, Biberach, Germany.
Email: anita.hennige@boehringer-ingelheim.com
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Carel W. le Roux PhD,
Carel W. le Roux PhD
* orcid.org/0000-0001-5521-5445
St. Vincent's University Hospital and University College Dublin, Dublin, Ireland
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Oren Steen MD,
Oren Steen MD
Private practice, Toronto, Ontario, Canada
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Kathryn J. Lucas MD,
Kathryn J. Lucas MD
Diabetes and Endocrinology Consultants, Morehead City, North Carolina, USA
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Elif I. Ekinci PhD,
Elif I. Ekinci PhD
* orcid.org/0000-0003-2372-395X
Austin Health, Heidelberg, Victoria, Australia
The Australian Centre for Accelerating Diabetes Innovation, University of
Melbourne, Parkville, Victoria, Australia
Department of Medicine, Melbourne Medical School, University of Melbourne,
Melbourne, Victoria, Australia
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Elena Startseva MD,
Elena Startseva MD
Boehringer Ingelheim International GmbH, Ingelheim, Germany
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Anna Unseld MSc,
Anna Unseld MSc
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
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Samina Ajaz Hussain MD,
Samina Ajaz Hussain MD
Boehringer Ingelheim International GmbH, Ingelheim, Germany
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Anita M. Hennige MD,
Corresponding Author
Anita M. Hennige MD
* anita.hennige@boehringer-ingelheim.com
* orcid.org/0000-0002-5149-4966
Boehringer Ingelheim International GmbH, Biberach, Germany
Correspondence
Anita M. Hennige, Boehringer Ingelheim International GmbH, Biberach, Germany.
Email: anita.hennige@boehringer-ingelheim.com
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First published: 25 November 2024
https://doi.org/10.1111/dom.16052
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* 1 INTRODUCTION
* 2 METHODS
* 3 RESULTS
* 4 DISCUSSION AND CONCLUSION
* AUTHOR CONTRIBUTIONS
* ACKNOWLEDGEMENTS
* FUNDING INFORMATION
* CONFLICT OF INTEREST STATEMENT
* Open Research
* REFERENCES
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1 INTRODUCTION
Obesity is a major risk factor for hypertension and increases the risk of
cardiovascular disease.1 Sustained weight loss is associated with improved blood
pressure (BP) control, with systolic BP (SBP) reductions of 5–20 mmHg per 10 kg
weight loss.2 Survodutide (BI 456906) is a glucagon receptor/GLP-1 receptor dual
agonist in clinical development for the treatment of obesity,3 and metabolic
dysfunction-associated steatohepatitis (MASH) with fibrosis.4 In a phase 2
clinical trial in adults with a BMI ≥27 kg/m2 without diabetes
(ClinicalTrials.gov, number NCT04667377), survodutide therapy led to significant
and dose-dependent reductions in body weight versus placebo (survodutide:
0.6 mg, p = 0.026; ≥2.4 mg, p < 0.001).5 Mean changes in body weight reached
−14.9% and − 18.7% at week 46 for planned (all data) and actual treatment
(on-treatment data), respectively, with survodutide 4.8 mg, versus −2.8%
and − 2.3% with placebo.5 Mean reductions in BP at week 46 with survodutide
4.8 mg by planned treatment were 8.6 mmHg for SBP and 4.8 mmHg for diastolic BP
(DBP), versus 2.5 mmHg for SBP and 1.9 mmHg for DBP with placebo; and similar
reductions occurred by actual treatment, with reductions of 8.3 mmHg for SBP and
4.7 mmHg for DBP with survodutide, versus 2.5 mmHg for SBP and 1.9 mmHg for DBP
with placebo.5 The tolerability profile of survodutide was similar to that of
GLP-1 receptor mono-agonists; gastrointestinal disorders were the most frequent
treatment-emergent adverse events (AEs).5
Here, we report a post hoc analysis to investigate the efficacy of survodutide
on BP parameters in subgroups with or without hypertension at baseline in people
with a BMI ≥27 kg/m2.
2 METHODS
Data were derived from a 46-week, randomized, double-blind, placebo-controlled,
dose-finding phase 2 trial of survodutide (ClinicalTrials.gov, number
NCT04667377, EudraCT, number 2020-002479-37).5 Briefly, 387 adults (aged ≥18 to
<75 years) with a BMI ≥27 kg/m2 and without diabetes were randomized 1:1:1:1:1
to receive once-weekly subcutaneous survodutide (0.6, 2.4, 3.6, or 4.8 mg) or
placebo for 46 weeks, comprising an initial 20-week dose-escalation period (dose
adjusted for gastrointestinal tolerability), followed by a 26-week
dose-maintenance period.5 The primary end-point was the percentage change in
body weight from baseline to week 46. In this post hoc analysis, changes from
baseline to week 46 in SBP and DBP (via office BP measurement) were evaluated by
the presence or absence of hypertension at baseline, defined as
investigator-reported before and at screening. Data were analysed descriptively
for the full analysis set (FAS), defined as all randomized participants
receiving ≥1 dose of study drug with data for ≥1 efficacy end-point, according
to doses received during the maintenance period (actual treatment) or those
assigned at randomization (planned treatment) using on-treatment data.5
3 RESULTS
In total, 387 participants were randomized (withdrawal, n = 1); 386 participants
received survodutide or matched placebo during the dose-escalation phase and 286
during the dose-maintenance phase. The FAS consisted of 384 participants (lack
of post-baseline efficacy data, n = 2).5 Baseline demographic and clinical
characteristics were similar across treatment groups.5 In the FAS, the majority
of participants were female (262; 68.2%) and White (301; 78.4%). At baseline,
133 (34.6%) participants had hypertension and 108 (28.1%) had dyslipidaemia.
At week 46, reductions in SBP and DBP were observed in all survodutide dose
groups tested when participants were analysed according to the presence or
absence of hypertension at baseline (Figure 1). The largest mean reductions in
SBP and DBP occurred in the survodutide 2.4 and 3.6 mg dose groups, and were
slightly larger in participants who were normotensive at baseline: SBP decreases
were 9.9 and 11.8 mmHg by planned treatment, and 9.7 and 12.0 mmHg by actual
treatment, respectively; and DBP decreases were 5.6 and 4.5 mmHg by planned
treatment, and 5.4 and 4.5 mmHg by actual treatment, respectively. The most
common concomitant antihypertensive agents taken during the treatment period
were angiotensin II receptor blockers (52; 13.5%), angiotensin-converting enzyme
inhibitors (39; 10.1%), beta blockers (31; 8.0%) and calcium channel blockers
(31; 8.0%). No important changes from baseline in the use of antihypertensive
medications were observed across treatment groups to week 46.
FIGURE 1
Open in figure viewerPowerPoint
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from
baseline to week 46 by hypertension status at baseline a (full analysis set,
on-treatment data). Descriptive statistics are presented. a Defined as: before
and at screening. SD, standard deviation. (A) Planned treatment. (B) Actual
treatment.
Five participants receiving survodutide reported AEs of hypotension (two of whom
had underlying hypertension), and one AE in a participant receiving placebo
(with underlying hypertension); in addition, two AEs of orthostatic hypotension
were reported in participants receiving survodutide (none with underlying
hypertension). None of these AEs were serious, but one case was graded as severe
(survodutide 4.8 mg dose group in the participant with underlying hypertension).
Reductions in SBP in participants without hypertension at baseline (i.e.,
normotensive) were not associated with any severe or serious hypotensive
episodes.
4 DISCUSSION AND CONCLUSION
All tested doses of survodutide were associated with clinically meaningful
decreases in SBP and DBP. Reductions in BP occurred regardless of the presence
or absence of hypertension at baseline. Our results are consistent with
preliminary analyses showing beneficial effects of incretin-based mono- and
dual-agonists in BP-lowering in people with a BMI ≥27 kg/m2 without diabetes.6-8
However, incretin-based agents with regulatory approval to treat obesity are not
yet approved to treat hypertension.
Anti-hypertension medications need to be monitored in patients receiving
survodutide, as hypotension may occur if doses of these agents are not adjusted.
However, caution is needed, because stopping all antihypertensives, especially
agents with known cardiovascular benefits, may offset the benefits observed with
survodutide.
This analysis has limitations: it was exploratory in nature, the trial
population was predominantly female and White and the trial duration was
relatively short. These points will be addressed in phase 3 trials currently in
progress (SYNCHRONIZE™-1, NCT06066515; SYNCHRONIZE™-2, NCT06066528; and
SYNCHRONIZE™-CVOT, NCT06077864). Inflammatory markers will also be evaluated in
phase 3 trials, as improvements in inflammation may underpin many of the
potential benefits of survodutide on end-organ damage.
As there did not appear to be a dose–response relationship, it is possible that
the observed reductions in BP could be secondary to weight loss and increased
activity/exercise. Hypertension reduction strategies based on lifestyle changes
have been shown to improve BP control,9 including short-term intensive diet and
exercise programmes,10 and longer-term e-counselling approaches.11
In conclusion, survodutide was associated with clinically meaningful
improvements in BP, regardless of hypertension status at baseline. These results
complement published phase 2 efficacy data, which demonstrated a dose-dependent
reduction in body weight with survodutide,5 and suggest that survodutide may
help to alleviate cardiovascular risk.
AUTHOR CONTRIBUTIONS
Design: Carel W. le Roux and Anita M. Hennige. Conduct/data collection: Oren
Steen, Kathryn J. Lucas and Elif I. Ekinci. Analysis: Carel W. le Roux, Elena
Startseva, Anna Unseld, Samina Ajaz Hussain and Anita M. Hennige. Writing
manuscript: All authors contributed to manuscript writing (assisted by a medical
writer paid for by the funder), approved the final version of the manuscript and
vouched for data accuracy and fidelity to the protocol.
ACKNOWLEDGEMENTS
The authors thank the study participants, investigators and study site staff.
Medical writing support in the preparation of this manuscript was provided by
Debra Brocksmith, MB ChB, PhD, of Elevate Scientific Solutions LLC, a member of
the Envision Pharma Group, and was funded by Boehringer Ingelheim. Boehringer
Ingelheim was given the opportunity to review the manuscript for medical and
scientific accuracy, as well as intellectual property considerations.
Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with
Boehringer Ingelheim solely responsible for development and commercialization
globally. Zealand has a co-promotion right in the Nordic countries.
FUNDING INFORMATION
This study was supported by Boehringer Ingelheim.
CONFLICT OF INTEREST STATEMENT
The authors meet criteria for authorship as recommended by the International
Committee of Medical Journal Editors (ICMJE) and did not receive payment related
to the development of this manuscript. Carel W. le Roux has received personal
fees from Boehringer Ingelheim, Eli Lilly, GI Dynamics, Gila Pharmaceuticals,
Herbalife, Johnson & Johnson, Keyron, Novo Nordisk and Zealand Pharma outside
the submitted work. Oren Steen has received research support from Alnylam, Anji,
AstraZeneca, Boehringer Ingelheim, CRISPR Therapeutics, Eli Lilly, Gilead
Sciences, Janssen, Kowa, Medicago, Moderna, Novartis, Novo Nordisk, Pfizer,
Sanofi, ViaCyte and Zucara Therapeutics; speaker bureau fees from Abbott, Amgen,
AstraZeneca, Bausch Health, Boehringer Ingelheim, Eli Lilly, Janssen, LMC, Novo
Nordisk and Sanofi; and consultancy fees from Amgen, Bayer, Eli Lilly, Novo
Nordisk and Sanofi. Kathryn J. Lucas has nothing to disclose. Elif I. Ekinci is
a consultant for Eli Lilly Australia, and her institute receives research
funding support from Amgen, Bayer, Boehringer Ingelheim, Eli Lilly Australia and
Versanis. Elena Startseva, Anna Unseld, Samina Ajaz Hussain and Anita M. Hennige
are employees of Boehringer Ingelheim.
OPEN RESEARCH
PEER REVIEW
The peer review history for this article is available at
https://www.webofscience.com/api/gateway/wos/peer-review/10.1111/dom.16052.
DATA AVAILABILITY STATEMENT
To ensure independent interpretation of clinical study results and enable
authors to fulfil their role and obligations under the ICMJE criteria,
Boehringer Ingelheim grants all external authors access to relevant clinical
study data. In adherence with the Boehringer Ingelheim Policy on Transparency
and Publication of Clinical Study Data, scientific and medical researchers can
request access to clinical study data, typically, 1 year after the approval has
been granted by major Regulatory Authorities or after termination of the
development programme. Researchers should use the https://vivli.org/ link to
request access to study data and visit
https://www.mystudywindow.com/msw/datasharing for further information.
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Early View
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* FIGURES
* REFERENCES
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© 2024 Boehringer Ingelheim International GmbH and The Author(s). Diabetes,
Obesity and Metabolism published by John Wiley & Sons Ltd.
This is an open access article under the terms of the Creative Commons
Attribution-NonCommercial License, which permits use, distribution and
reproduction in any medium, provided the original work is properly cited and is
not used for commercial purposes.
* Check for updates
RESEARCH FUNDING
* Boehringer Ingelheim
KEYWORDS
* blood pressure
* dual agonism
* glucagon receptor agonist
* glucagon-like peptide-1 receptor agonist
* obesity
* overweight
* survodutide
PUBLICATION HISTORY
* Version of Record online: 25 November 2024
* Manuscript accepted: 22 October 2024
* Manuscript revised: 22 October 2024
* Manuscript received: 20 June 2024
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