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NCT06066515CompletedPhase 3

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity Without Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
726 (actual)
First submitted
27 Sept 2023
Start date
25 Nov 2023
Primary completion date
2 Dec 2025
Lead sponsor
Boehringer Ingelheim
NCT number
NCT06066515
EU CT number
2022-502529-17-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 726
  • From 25 Nov 2023 to the primary completion date, 2 Dec 2025
  • 123 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Body weight change (self-reported) of \>5% within 3 months before screening.
  • Treatment with any medication for the indication obesity within 3 months before screening.

Other illness

  • Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
    • Further exclusion criteria apply.

Lab values

  • Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
  • History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
  • History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase \>2x upper limit of normal (ULN) as measured by the central laboratory at screening.

Other

  • Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).

Who the study is looking for

  • Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years
  • Body mass index (BMI) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
    • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
    • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol 50 mg/dL (\<1.3 mmol/L) for women)
    • Obstructive sleep apnoea
    • Others.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.
    • Further inclusion criteria apply.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (123)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Monash University
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Box HillAustraliaUnknown status
Austin Health
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HeidelbergAustraliaUnknown status
Baker Heart and Diabetes Institute
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MelbourneAustraliaUnknown status
Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
Core Research Group
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MiltonAustraliaUnknown status
Keogh Institute for Medical Research
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NedlandsAustraliaUnknown status
Griffith Health
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SouthportAustraliaUnknown status
Algemeen Stedelijk Ziekenhuis - campus Aalst
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AalstBelgiumCompleted
Hopital Erasme
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AnderlechtBelgiumCompleted
Antwerp University Hospital
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EdegemBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
AZ Delta
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RoeselareBelgiumCompleted
Aggarwal and Associates Ltd
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BramptonCanadaUnknown status
ViaCar Recherches Cliniques Inc. (Greenfield Park)
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Greenfield ParkCanadaUnknown status
The Wharton Medical Clinic Clinical Trials Inc
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HamiltonCanadaUnknown status
Milestone Research Inc.
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LondonCanadaUnknown status
Power Clinical Research
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MontrealCanadaUnknown status
James Cha, MD
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OshawaCanadaUnknown status
Stouffville Medical Research Institute Inc.
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StouffvilleCanadaUnknown status
Albion Finch Medical Centre
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TorontoCanadaUnknown status
Dr. James Lai
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VancouverCanadaUnknown status
Sameh Fikry Medicine Professional Corporation
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WaterlooCanadaUnknown status
Beijing Pinggu Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Changzhou Second People's Hospital
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ChangzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Forth Clinical Hospital of Harbin Medical University
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HarbinChinaUnknown status
Huzhou Central Hospital
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HuzhouChinaUnknown status
Center Hospital of Jinan
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JinanChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Shanghai Fifth People's Hospital Affiliated to Fudan University
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ShanghaiChinaUnknown status
Shanghai Municipal Hospital of Traditional Chinese Medicine
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ShanghaiChinaUnknown status
Siping Central People's Hospital
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SipingChinaUnknown status
Suzhou Municipal Hospital
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SuzhouChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Xi'an Medical University
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Xi'anChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
InnoDiab Forschung Gmbh
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EssenGermanyCompleted
MVZ im Altstadt-Carree Fulda GmbH
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FuldaGermanyCompleted
Diabetes Zentrum Hamburg West
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HamburgGermanyCompleted
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyCompleted
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyCompleted
KliFoCenter GmbH
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WittenGermanyCompleted
HUS Helsinki University Hospital
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HelsinkiFinlandCompleted
Studycor Oy
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JyväskyläFinlandCompleted
Health Step Finland Oy
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KuopioFinlandCompleted
Clinical Research Services Turku Oy
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TurkuFinlandCompleted
Waterloo Medical Centre
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BlackpoolUnited KingdomUnknown status
Bradford on Avon Health Centre
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Bradford on AvonUnited KingdomUnknown status
Burbage Surgery
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Burbage, HinkleyUnited KingdomUnknown status
Kiltearn Medical Centre
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NantwichUnited KingdomUnknown status
Clifton Medical Centre, Rotherham
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RotherhamUnited KingdomUnknown status
Trowbridge Health Centre
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TrowbridgeUnited KingdomUnknown status
Fukuhama Chuo Clinic
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Fukuoka, FukuokaJapanUnknown status
Kobe University Hospital
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Hyogo, KobeJapanUnknown status
Noritake Clinic
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Ibaraki, UshikuJapanUnknown status
Soka Sugiura Naika Clinic
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Saitama, SokaJapanUnknown status
Hachioji Diabetes Clinic
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Tokyo, HachiojiJapanUnknown status
The Catholic University of Korea, Bucheon St. Mary's Hospital
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Bucheon-siSouth KoreaUnknown status
Kyungpook National University Hospital
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DaeguSouth KoreaUnknown status
Dongguk University Ilsan Hospital
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GoyangSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
The Catholic University of Korea Yeouido St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
PreCare Trial & Recruitment B.V.
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BornNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Stichting Treant Ziekenhuiszorg
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HoogeveenNetherlandsCompleted
Sint Franciscus Vlietland Groep Stichting
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RotterdamNetherlandsCompleted
P3 Research Dunedin
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DunedinNew ZealandUnknown status
Southern Clinical Trials Tasman
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NelsonNew ZealandUnknown status
P3 Research-Newtown Wellington NZ-33770
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Newtown Wellington NZNew ZealandUnknown status
Optimal Clinical Trials North
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Rosedale, AucklandNew ZealandUnknown status
P3 Research-Tauranga-34833
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TaurangaNew ZealandUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
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LublinPolandCompleted
Velocity Nova Sp. z o.o.
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PulawyPolandCompleted
Lukmed 2 Sp. z o.o.
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SiedlcePolandCompleted
Metabolica Sp. z o.o.
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TarnówPolandCompleted
Ladulaas AB
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BorasSwedenCompleted
Stift Carlanderska Sjukhuset
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GoteborgSwedenCompleted
PharmaSite AB
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MalmoSwedenCompleted
Region Oerebro Laen
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OrebroSwedenCompleted
Region Stockholm – SLSO
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StockholmSwedenCompleted
Texas Diabetes and Endocrinology
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AustinUnited StatesUnknown status
Velocity Clinical Research - Binghamton
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BinghamtonUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
Alliance for Multispecialty Research, LLC - Doral
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DoralUnited StatesUnknown status
Valley Weight Loss Clinic
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FargoUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Physicians East, PA
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GreenvilleUnited StatesUnknown status
East-West Medical Research
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HonoluluUnited StatesUnknown status
Juno Research, LLC
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HoustonUnited StatesUnknown status
East Coast Institute for Research, LLC - Jacksonville
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JacksonvilleUnited StatesUnknown status
AMR Lexington
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LexingtonUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Solaris Clinical Research
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MeridianUnited StatesUnknown status
New Horizon Research Center-Miami-69732
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MiamiUnited StatesUnknown status
Lucas Research, Inc.
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Morehead CityUnited StatesUnknown status
Trial Management Associates
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Myrtle BeachUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
EmVenio Research-Oklahoma City-70053
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Oklahoma CityUnited StatesUnknown status
EmVenio Research-Phoenix-69743
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PhoenixUnited StatesUnknown status
Rainier Clinical Research Center
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RentonUnited StatesUnknown status
Diabetes & Glandular Disease Clinic, P.A.
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San AntonioUnited StatesUnknown status
Consano Clinical Research
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Shavano ParkUnited StatesUnknown status
Velocity Clinical Research-Sioux City-69728
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Sioux CityUnited StatesUnknown status
Evanston Premier Healthcare Research, LLC
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SkokieUnited StatesUnknown status
Encompass Clinical Research_Spring Valley
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Spring ValleyUnited StatesUnknown status
Premier Research Inc.
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TrentonUnited StatesUnknown status
Velocity Clinical Research-Valparaiso-68883
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ValparaisoUnited StatesUnknown status
Diablo Clinical Research
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Walnut CreekUnited StatesUnknown status
Southgate Medical Group/ Southgate Medical Park
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West SenecaUnited StatesUnknown status
Accellacare-Wilmington-67123
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WilmingtonUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.