A Research Study to Look at How Well Zenagamtide Works Compared to Placebo in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity
Zenagamtide Use for the Reduction of Risk of Major Adverse Cardiovascular Events in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe zenagamtide is and how well it works in people with artery disease caused by fatty buildup who are overweight or have obesity. Half will get zenagamtide, and half will get a placebo with no active medicine, chosen by chance. Zenagamtide is a study medicine that doctors cannot yet prescribe.
This clinical study is being conducted to evaluate the safety and effectiveness of zenagamtide in people with atherosclerotic cardiovascular disease (ASCVD) and excess body weight compared with placebo. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have ASCVD and excess body weight. Participants will be randomly assigned by chance to receive either zenagamtide, the investigational treatment being tested, or a placebo, which contains no active medicine. Half of the participants will receive zenagamtide, and treatment assignment will be determined randomly. Zenagamtide is a new investigational medicine that is not yet available for prescription by doctors.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must have had a heart attack, a stroke, or one of the listed forms of artery disease in your legs.
- Qualifying leg artery disease means pain when walking with an ankle-to-arm blood pressure ratio below 0.85 at rest, or a leg or foot removed at or above the ankle because of fatty buildup in arteries.
- If you have type 2 diabetes, your treatment must have been stable for at least 90 days before screening, as judged by the study doctor.
- Diabetes medicines must follow local prescribing rules. GLP-1, GIP, and amylin medicines are not allowed. If you use insulin, only basal (background) insulin is allowed.
Who can't join
- A heart attack, stroke, unstable chest pain, or worsening heart failure that led to a hospital stay or water-removing medicine given into a vein, from 30 days before screening through assignment to a study group.
- A procedure to restore blood flow in heart, neck, or limb arteries, or a heart valve repair or replacement through a thin tube, within 30 days before screening or planned during the study.
- Long-term heart failure identified at screening.
- Repeated episodes of severely low blood sugar in the past year, or a known history of not noticing low blood sugar.
- A history of type 1 diabetes.
- Diabetes-related eye damage treated with laser, surgery, or anti-VEGF medicine within 180 days before screening, or expected to need treatment within 180 days after screening. An eye exam must check for this damage.
- An HbA1c result above 10% at screening. This blood test measures average blood sugar.
- Use of any GLP-1, GIP, or amylin medicine for any reason before screening.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Established ASCVD is defined as at least one of the below conditions (a-c): a. Prior myocardial infarction (MI) b. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) less than (\<) 0.85 at rest ii. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) c. Cerebrovascular disease defined as the following: i. Prior stroke * Participants with Type 2 Diabetes (T2D) (at screening) are allowed in the study with the following provisions: 1. Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator. 2. Glucose lowering agents are permitted according to local label except glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) and amylin analogues; for insulins, only basal insulin is allowed. Exclusion Criteria: * MI, stroke, unstable angina pectoris, or worsening heart failure (HF) leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * Coronary, carotid, or peripheral artery revascularization or percutaneous valve repair or replacement within 30 days prior to the day of screening or planned during the study period and known at screening. * Chronic heart failure classified at screening. * Glycaemia-related: 1. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 2. Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. 3. History of type 1 diabetes (T1D). 4. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 5. Glycated haemoglobin (HbA1c) greater than (\>) 10 percentage (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening. * General health and safety: 1. Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before screening.
Study sites (155)
AL
- Uni of Alabama at Birmingham · Birmingham, AL 35294More trials in Birmingham
- Eastern Shore Rsrch Inst, LLC · Fairhope, AL 36532More trials in Fairhope
- Mobile Heart Specialists · Mobile, AL 36608More trials in Mobile
- Chambliss Clinical Trials LLC · Montgomery, AL 36106More trials in Montgomery
AZ
- Mercy Gilbert Medical Center · Gilbert, AZ 85297More trials in Gilbert
- Sun City Clinical Research · Glendale, AZ 85304More trials in Glendale
- Honor Health · Scottsdale, AZ 85258More trials in Scottsdale
- Clinical Research Institute of Arizona · Surprise, AZ 85374More trials in Surprise
CA
- National Heart Institute Cal · Beverly Hills, CA 90211More trials in Beverly Hills
- California Inst Of Renal Res · Chula Vista, CA 91910More trials in Chula Vista
- Valley Clinical Trials · Covina, CA 91723More trials in Covina
- First Valley Medical Group · Lancaster, CA 93534More trials in Lancaster
- Torrance Clin Res Inst, Inc. · Lomita, CA 90717More trials in Lomita
- Pacific Clinical Studies · Los Alamitos, CA 90720More trials in Los Alamitos
- Academic Medical Research Institute · Los Angeles, CA 90022More trials in Los Angeles
- Valley Clinical Trials, Inc. · Northridge, CA 91325More trials in Northridge
- Desert Oasis Hlthcr Med Group · Palm Springs, CA 92262More trials in Palm Springs
- Clinical Trials Research_Sacramento · Sacramento, CA 95821More trials in Sacramento
- Paradigm Clinical Research · San Diego, CA 92108More trials in San Diego
- N America Res Inst - San Dimas · San Dimas, CA 91773More trials in San Dimas
- Fomat Medical Research · Santa Maria, CA 93454More trials in Santa Maria
CT
- Bridgeport Hospital · Bridgeport, CT 06610More trials in Bridgeport
FL
- Innovative Research of W FL · Clearwater, FL 33756More trials in Clearwater
- Nature Coast Clin Rsrch_Crystal River · Crystal River, FL 34429More trials in Crystal River
- Florida Premier Cardiology · Delray Beach, FL 33484More trials in Delray Beach
- Encore Medical Research LLC · Hollywood, FL 33024More trials in Hollywood
- Est Cst Inst for Rsrch,Jksnvil · Jacksonville, FL 32216More trials in Jacksonville
- Jacksonville Ctr Clin Res · Jacksonville, FL 32216More trials in Jacksonville
- Clinical Research of Cent FL · Lakeland, FL 33805More trials in Lakeland
- K2 Medical Research · Maitland, FL 32751More trials in Maitland
- Life Spring Research Foundation LLC · Miami, FL 33130More trials in Miami
- Flourish Research - North Miami · Miami, FL 33138More trials in Miami
- Oceane 7 Medical & Research Center, Inc. · Miami, FL 33144More trials in Miami
- San Marcus Res Clin Miami Lakes · Miami Lakes, FL 33014More trials in Miami Lakes
- Advance Rsch for Hlth Improvement_Naples · Naples, FL 34102More trials in Naples
- Suncoast Clinical Research, Inc. · New Port Richey, FL 34652More trials in New Port Richey
- Ocala Cardiovascular Research · Ocala, FL 34471More trials in Ocala
- Oviedo Medical Research, LLC · Oviedo, FL 32765More trials in Oviedo
- Cardio Partners Clin Res Inst · Palm Beach Gardens, FL 33410More trials in Palm Beach Gardens
- Suncoast Clinical Research, Inc. · Palm Harbor, FL 34684More trials in Palm Harbor
- Suncoast Research Associates LLC · Pembroke Pines, FL 33024More trials in Pembroke Pines
- Florida Kidney Physicians LLC · Riverview, FL 33578More trials in Riverview
- Care Access · Tamarac, FL 33321More trials in Tamarac
- Cardiovascular Associates of America · Wellington, FL 33449-8095More trials in Wellington
GA
- Javara/Privia Med Grp GA,LLC · Albany, GA 31707More trials in Albany
- West Georgia Cardiology · Carrollton, GA 30117More trials in Carrollton
- Cardiovascular Care Center & CRC · Conyers, GA 30012More trials in Conyers
- Hope Clin Res & Wellness · Conyers, GA 30094More trials in Conyers
- Core Clinical Trials · Cordele, GA 31015More trials in Cordele
- NSC Research, Inc · Johns Creek, GA 30024More trials in Johns Creek
- GA Arrhythmia Cons & Rsch Inst · Macon, GA 31201More trials in Macon
- Ukpong Cardiology Service · Moultrie, GA 31768More trials in Moultrie
- Javara Inc. / Privia Medical Group Georgia LLC · Peachtree City, GA 30269More trials in Peachtree City
- Atlanta Heart Specialist · Tucker, GA 30084More trials in Tucker
IA
- West Broadway Clinic · Council Bluffs, IA 51501More trials in Council Bluffs
- University of Iowa Prev Inter Ctr · Iowa City, IA 52772More trials in Iowa City
- Iowa Diab & Endo Res Center · West Des Moines, IA 50266More trials in West Des Moines
ID
- Rocky Mountain Diab&Osteo Ctr · Idaho Falls, ID 83404-7596More trials in Idaho Falls
IL
- Macoupin Research Group · Gillespie, IL 62033More trials in Gillespie
- Elevate Clinical Research · Gurnee, IL 60031More trials in Gurnee
- Chicago Medical Research LLC · Hazel Crest, IL 60429More trials in Hazel Crest
- Cardiovascular Associates of America · Moline, IL 61265More trials in Moline
- Genesis Orthopedics & Sports Medicine · Oak Brook, IL 60523More trials in Oak Brook
- UnityPoint Health-Diabetes Care Center · Peoria, IL 61603More trials in Peoria
- Cardiovascular Associates of America · Schaumburg, IL 60173More trials in Schaumburg
IN
- American Health Network of Indiana, LLC_Avon_0 · Avon, IN 46123More trials in Avon
- American Health Network of IN LLC_Franklin · Franklin, IN 46131More trials in Franklin
- American Health Network of Indiana, LLC_Greenfield · Greenfield, IN 46140More trials in Greenfield
- American Health Network of IN LLC · Muncie, IN 47304More trials in Muncie
KS
- Cotton O'Neil Diab & Endo Ctr · Topeka, KS 66606More trials in Topeka
KY
- The Research Group of Lexington LLC · Lexington, KY 40503More trials in Lexington
- Norton Clinical Research Group · Louisville, KY 40217More trials in Louisville
LA
- Grace Research, LLC · Bossier City, LA 71111More trials in Bossier City
- Louisiana Heart Center · Covington, LA 70433More trials in Covington
- Louisiana Heart Center_Slidell · Slidell, LA 70458More trials in Slidell
MD
- MedStar Good Samaritan Hosp · Baltimore, MD 21044More trials in Baltimore
- Ascension Saint Agnes Heart Ca · Baltimore, MD 21229More trials in Baltimore
- Flourish Research Bowie · Bowie, MD 20715More trials in Bowie
- Centennial Medical Group · Columbia, MD 21045More trials in Columbia
MI
- Henry Ford Health System · Detroit, MI 48202More trials in Detroit
- Elite Research Center · Flint, MI 48532More trials in Flint
- Arcturus Healthcare, PLC. · Troy, MI 48098More trials in Troy
- Trinity Health Michigan Heart · Ypsilanti, MI 48197More trials in Ypsilanti
MO
- Clinical Research Professionals · Chesterfield, MO 63005More trials in Chesterfield
- Clinical Research Consultants · Kansas City, MO 64111More trials in Kansas City
- The Alliance for Multispecialty Research LLC AMR · Kansas City, MO 64114More trials in Kansas City
- Headlands Research · Springfield, MO 65807More trials in Springfield
- Amicis Centers of Clinical Research · St Louis, MO 63128More trials in St Louis
NC
- Durham Nephrology Associates · Durham, NC 27704More trials in Durham
- Medication Mgmnt, LLC_Grnsboro · Greensboro, NC 27405More trials in Greensboro
- Carteret Medical Group · Morehead City, NC 28557More trials in Morehead City
- Piedmont Healthcare/Research · Statesville, NC 28625More trials in Statesville
ND
- Lillestol Research LLC · Fargo, ND 58104More trials in Fargo
NE
- VA NEB - Western IA Health Stm · Omaha, NE 68105More trials in Omaha
- University of Nebraska Medical Center · Omaha, NE 68198More trials in Omaha
NH
- Seacoast Kidney & Htn Specialists · Portsmouth, NH 03801More trials in Portsmouth
NV
- Palm Research Center Inc-Vegas · Las Vegas, NV 89128More trials in Las Vegas
NY
- Central New York Clinical Research CNYCR · Manlius, NY 13104More trials in Manlius
- Mid Hudson Med Res-New Windsor · New Windsor, NY 12553More trials in New Windsor
- NYU School of Medicine · New York, NY 10016More trials in New York
- NYC Health + Hospitals/Lincoln · The Bronx, NY 10451More trials in The Bronx
- Great Lakes Medical Research · Westfield, NY 14787More trials in Westfield
OH
- Univ of Cincinnati Med Cent · Cincinnati, OH 45267More trials in Cincinnati
- Advanced Med Res Maumee · Maumee, OH 43537More trials in Maumee
OK
- Tekton Research Inc · Moore, OK 73160More trials in Moore
- Lynn Institute of Norman · Norman, OK 73072More trials in Norman
PA
- Heritage Valley Medical Group · Beaver, PA 15009More trials in Beaver
- Capital Area Research LLC · Newport, PA 17074More trials in Newport
- Aria Endocrine Metabolic Assoc · Philadelphia, PA 19114More trials in Philadelphia
SC
- Piedmont Research Partners, LLC · Fort Mill, SC 29707More trials in Fort Mill
- Carolina Nephrology Clinical Research · Greenville, SC 29605More trials in Greenville
- Accellacare US Inc._SC · Mt. Pleasant, SC 29464More trials in Mt. Pleasant
- Carolina Health Specialists · Myrtle Beach, SC 29572More trials in Myrtle Beach
TN
- Holston Medical Group Pc · Bristol, TN 37620-7352More trials in Bristol
- Holston Medical Group · Kingsport, TN 37660More trials in Kingsport
- MidState Endocrine Associates · Nashville, TN 37203More trials in Nashville
TX
- PharmaTex Research · Amarillo, TX 79109More trials in Amarillo
- Ascension Texas Cardiovascular · Austin, TX 78705More trials in Austin
- Pinnacle Clinical Research · Austin, TX 78757More trials in Austin
- Metropolitan Cardiology PA · Beaumont, TX 77701More trials in Beaumont
- Javara Inc. / Privia Medical Group Gulf Coast PLLC · Conroe, TX 77384More trials in Conroe
- South Texas Clinical Research · Corpus Christi, TX 78404More trials in Corpus Christi
- Thyroid Endocrinology & Diabetes PA · Dallas, TX 75208More trials in Dallas
- Baylor Jack and Jane Hamilton · Dallas, TX 75226More trials in Dallas
- Liberty Research Center_Dallas · Dallas, TX 75230More trials in Dallas
- Forefront Med Res Inst PLLC · Harlingen, TX 78550More trials in Harlingen
- PrimeCare Medical Group · Houston, TX 77024More trials in Houston
- JCCT- Juno NW Houston · Houston, TX 77040More trials in Houston
- Northwest Houston Cardiology, P.A. · Houston, TX 77070More trials in Houston
- Endocrine And Psychiatry Center · Houston, TX 77095More trials in Houston
- DCOL Ctr for Clin Res · Longview, TX 75605More trials in Longview
- Texas Inst, Kdny & Endo Disor · Lufkin, TX 75904More trials in Lufkin
- PRX Research · Mesquite, TX 75149More trials in Mesquite
- Ascension Texas Cardiovascular · Round Rock, TX 78665More trials in Round Rock
- Clinical Advancement Center · San Antonio, TX 78212More trials in San Antonio
- Sun Research Institute · San Antonio, TX 78215More trials in San Antonio
- The IMA Group IMA Clinical Trials of America Inc. CTA · San Antonio, TX 78229More trials in San Antonio
- Univ Of Texas Hlth Science Cntr · San Antonio, TX 78229More trials in San Antonio
- VIP Trials · San Antonio, TX 78230More trials in San Antonio
- Simcare Medical Research, LLC · Sugar Land, TX 77478More trials in Sugar Land
- Houston Research Institute · Sugar Land, TX 77479More trials in Sugar Land
- Northwest Houston Clinical Research, PLLC · Tomball, TX 77375More trials in Tomball
- Crossroads Clinical Res- Texas · Victoria, TX 77901More trials in Victoria
UT
- Progressive Clinical Research UT · Bountiful, UT 84010More trials in Bountiful
- AMR Clinical · Layton, UT 84041More trials in Layton
- Kalo Clinical Research · West Valley City, UT 84120More trials in West Valley City
VA
- Carient Heart and Vascular · Manassas, VA 20109More trials in Manassas
- TPMG Clinical Research · Newport News, VA 23606More trials in Newport News
- Sentara Health Research Center · Norfolk, VA 23507More trials in Norfolk
- Dominion Medical Associates · Richmond, VA 23219More trials in Richmond
- VA Medical Center_Salem · Salem, VA 24153-6404More trials in Salem
- Conquest Research · Vienna, VA 22182More trials in Vienna
- Selma Medical Associates · Winchester, VA 22601-3834More trials in Winchester
WA
- Providence Medical Research Center · Spokane, WA 99204More trials in Spokane
WI
- St. Vincent Hosp-Prevea Health · Green Bay, WI 54303More trials in Green Bay