ObesityPhase 2NCT04667377
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
A Phase 2 study testing BI 456906 in people with Obesity, run by Boehringer Ingelheim at 43 sites in 12 countries.
Trial summary
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- BI 456906
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 43 sitesin 12 countries
- Study dates
- 8 Mar 2021to 7 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years and < 75 years of age at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Obesity or Overweight defined as BMI ≥27 kg/m2 at screening
- A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
- Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement
Who cannot join
- Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization.
- Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)
- A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening
- Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period
- History of major depressive disorder within 2 years before randomization
Show all 10Show fewer
- Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 [PHQ-9] score ≥15) at screening and/or during screening period
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening
- Chronic or relevant acute infections (including but not limited to respiratory tract infections, urinary tract infection, bladder infection, enterocolitis, abscess, tuberculosis, meningitis, influenza, Epstein-Barr virus, HIV/AIDS, and hepatitis B or C, and severe acute respiratory syndrome coronavirus type 19 (SARS CoV-2) (as confirmed by Polychain reaction (PCR) test)), within 2 weeks from screening or during screening.
- Further exclusion criteria apply
Trial locations and contacts
43 sites in 12 countries.
43 sites in 12 countries
United States10 sites
Washington Center for Weight Management and Research, Inc.
Arlington, Virginia, 22206
Velocity Clinical Research, Inc.
Cleveland, Ohio, 44122
TLM Medical Services, LLC
Columbia, South Carolina, 29204
Valley Weight Loss Clinic
Fargo, North Dakota, 58104
L-MARC Research Center
Louisville, Kentucky, 40213
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Diablo Clinical Research
Walnut Creek, California, 94598
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Boden Initiative
Camperdown, New South Wales, 2006
Eastern Clinical Research Unit
East Ringwood, Victoria, 3135
Austin Health
Heidelberg, Victoria, 3081
Nepean Hospital
Kingswood, New South Wales, 2747
Canada5 sites
Joanne F Liutkus Medicine Professional Corporation
Cambridge, Ontario, N3H 4L5
Recherche GCP Research
Montreal, Quebec, H1M 1B1
Bluewater Clinical Research
Sarnia, Ontario, N7T 4X3
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, M4G 3E8
China4 sites
Beijing Chao-Yang Hospital
Beijing, 100020
Beijing Luhe Hospital Capital Medical University
Beijing, 101199
The First Hospital of Jilin University
Changchun, 130021
Wuhan Union Hospital
Wuhan, 430022
Netherlands4 sites
EB Flevoresearch
Almere Stad, 1311 RL
PT & R
Beek, 6191 JW
Franciscus Gasthuis
Rotterdam, 3045 PM
Albert SchweitzerZiekenhuis
Zwijndrecht, 3331 LZ
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam, 13620
Kyung Hee University Hospital at Gangdong
Seoul, 05278
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Sweden3 sites
Ladulaas Kliniska Studier
Borås, 506 30
Forskningsenheten Carlanderska
Gothenburg, 40545
Akademiska sjukhuset
Uppsala, 751 85
Germany2 sites
Klinische Forschung Berlin GbR
Berlin, 10787
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
New Zealand2 sites
Optimal Clinical Trials
Auckland, 1010
P3 Research
Newtown Wellington NZ, 6021
Poland2 sites
Salvia Lekston I Madej Sp. J.
Katowice, 40772
Metabolic Health Center Pawel Bogdanski
Poznan, 60592
United Kingdom2 sites
Waterloo Medical Centre
Blackpool, FY4 3AD
Clifton Medical Centre, Rotherham
Rotherham, S65 1DA
About this study
Official title: A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight.
Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine.
Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.
- Conditions
- Obesity
- Being tested
- BI 456906, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 456906Drug
Also called Survodutide
BI 456906
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mg BI 456906 | Experimental | Not described Receives: Drug: BI 456906 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| 2.4 mg BI456906 | Experimental | Not described Receives: Drug: BI 456906 |
| 3.6 mg BI 456906 | Experimental | Not described Receives: Drug: BI 456906 |
| 4.8 mg BI 456906 | Experimental | Not described Receives: Drug: BI 456906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Body Weight From Baseline to Week 46
Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".
Measured: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary outcomes (7)
Weight Loss of ≥ 5% of Baseline Weight at Week 46
Weight loss of greater than or equal to 5 percent (≥5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Measured: At baseline and at Week 46.
Weight Loss of ≥ 10% of Baseline Weight at Week 46
Weight loss of greater than or equal to 10 percent (≥10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Measured: At baseline and at Week 46.
Weight Loss of ≥ 15% of Baseline Weight at Week 46
Weight loss of greater than or equal to 15 percent (≥15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Measured: At baseline and at Week 46.
Absolute Change in Body Weight From Baseline to Week 46
Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Measured: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Waist Circumference From Baseline to Week 46
Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Measured: Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
Absolute Change in Systolic Blood Pressure From Baseline to Week 46
Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Measured: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Measured: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start8 Mar 2021
- Primary completion15 Sep 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667377
- Sponsor's protocol ID
- 1404-0036
- Other IDs
- 2020-002479-37
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2020
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Publications
Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Diabetes Obes Metab. 2026 Sep;28(9):8242-8253. doi: 10.1111/dom.70861. Epub 2026 Jun 22.
PubMed 42331726le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hussain SA, Hennige AM. Subgroup analysis by sex and baseline BMI in people with a BMI >/=27 kg/m2 in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist. Diabetes Obes Metab. 2025 Apr;27(4):1773-1782. doi: 10.1111/dom.16167. Epub 2025 Jan 16.
PubMed 39821928le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):162-173. doi: 10.1016/S2213-8587(23)00356-X. Epub 2024 Feb 5.
PubMed 38330987
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT04667377
- Acronym / sponsor ID
- 1404-0036
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight.
Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine.
Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.6 mg BI 456906 | Experimental | Drug: BI 456906 |
| Placebo group | Placebo comparator | Drug: Placebo |
| 2.4 mg BI456906 | Experimental | Drug: BI 456906 |
| 3.6 mg BI 456906 | Experimental | Drug: BI 456906 |
| 4.8 mg BI 456906 | Experimental | Drug: BI 456906 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult ≥ 18 years and < 75 years of age at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Obesity or Overweight defined as BMI ≥27 kg/m2 at screening
- A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
- Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Key exclusion criteria (10 listed)
- Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization.
- Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)
- A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening
- Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 456906Also: SurvodutideBI 456906 | Drug | 0.6 mg BI 456906, 2.4 mg BI456906, 3.6 mg BI 456906, 4.8 mg BI 456906 |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
Percentage Change in Body Weight From Baseline to Week 46
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".
7 secondary outcomes
Weight Loss of ≥ 5% of Baseline Weight at Week 46
Time frame: At baseline and at Week 46.
Weight Loss of ≥ 10% of Baseline Weight at Week 46
Time frame: At baseline and at Week 46.
Weight Loss of ≥ 15% of Baseline Weight at Week 46
Time frame: At baseline and at Week 46.
Absolute Change in Body Weight From Baseline to Week 46
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Waist Circumference From Baseline to Week 46
Time frame: Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
Absolute Change in Systolic Blood Pressure From Baseline to Week 46
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42331726Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Diabetes Obes Metab. 2026 Sep;28(9):8242-8253. doi: 10.1111/dom.70861. Epub 2026 Jun 22.
- Derived from this study: PubMed 39821928le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hussain SA, Hennige AM. Subgroup analysis by sex and baseline BMI in people with a BMI >/=27 kg/m2 in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist. Diabetes Obes Metab. 2025 Apr;27(4):1773-1782. doi: 10.1111/dom.16167. Epub 2025 Jan 16.
- Derived from this study: PubMed 38330987le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):162-173. doi: 10.1016/S2213-8587(23)00356-X. Epub 2024 Feb 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 456906 in people with Obesity, run by Boehringer Ingelheim at 43 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Australia, Canada, China, Netherlands and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight From Baseline to Week 46 (time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.