GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05933499

RecruitingPhase 2

Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity

Lead sponsor

Massachusetts General Hospital

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Lean mass

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05933499

Org study ID2023P001334

Timeline

Milestones

Study first posted2023-07-06actual

Study start2025-11-05actual

Last update posted2026-03-27actual

Primary completion2028-12-31estimated

Study completion2029-03-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥30 kg/m2 or ≥27kg/m2 with at least one weight-related medical condition

•Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight

•Have an established primary care provider

Exclusion criteria

•Current or prior history of diabetes mellitus based on self-report, use of diabetes medications, HbA1c ≥6.5%, or fasting glucose ≥126 mg/dL

•Any single serum transaminase level (i.e., ALT, AST, alk phos) ≥3x the upper limit of normal (ULN)

•Serum lipase and/or amylase levels ≥2x ULN

•Serum bilirubin level >1.6 mg/dL

•Chronic kidney disease (e.g., estimated glomerular filtration rate (eGFR) < 45 mL/min)

•Total WBC <3000/μL, neutrophils <1500/μL, hemoglobin <12 g/dL, or platelet count <100,000/μL

•Significant coagulopathy, e.g., PT/INR >1.5

•History of familial hypertriglyceridemia or serum fasting triglyceride >500 mg/dL

•Uncontrolled thyroid disease, defined as abnormal TSH with abnormal fT4

•Any chronic active infection (e.g., HIV, hepatitis B or C) or hepatitis C treatment within the previous 6 months

•Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) or conditions with hepatotoxic potential (e.g., gallbladder or bile duct disease, acute or chronic pancreatitis, exocrine pancreatic insufficiency)

•Active clinically significant gastric emptying abnormality or chronic use of a drug(s) that directly affect GI motility

•History of calcium oxalate kidney stones

•History of clinically significant arrhythmias, unstable angina, myocardial infarction, stroke, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, valve disorders or defect, pulmonary hypertension, chronic hypotension (<100/50), or chronic uncontrolled hypertension (>160/100)

•Tachycardia, defined as heart rate >100 bpm after 5 minutes resting in a sitting position

•History of malignancy of any organ system (other than localized squamous or basal cell carcinoma of the skin), treated or untreated, within the previous 5 years

•Confirmed diagnosis of current, significant psychiatric disease (e.g., dementia, Alzheimer's disease, schizophrenia, or bipolar disorder). Individuals with adequately treated depression on stable treatment for at least 3 months are eligible.

•Prior history of suicide attempt

•PHQ-9 score ≥ 15 at screening

•Personal or family history of multiple endocrine neoplasia 2A or 2B or medullary thyroid cancer

•Active alcohol, drug, or tobacco abuse. For alcohol, an average weekly alcohol intake that exceeds 14 units per week (males) or 7 units per week (females) [1 unit = 12 oz or 260 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits] is exclusionary.

•Cannabis/THC use greater than once a week over the past three months and unwilling to abstain from use of cannabis/THC products for the duration of the study

•Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader Willi syndrome)

•History of weight loss surgery or planned weight loss surgery during the trial period

•Use of any anti-obesity medication, nutritional supplement, or over the counter (OTC) product for weight loss within the previous 6 months or during study participation

•Any new dietary intervention or exercise regimen for weight loss started within the previous 3 months

•Weight instability of >5kg within the previous 3 months

•Weight > 150kg due to limitations of radiology imaging machines

•Use of medications known or suspected to induce weight gain within the previous 3 months or during study participation (e.g., anti-androgens, gonadotropin releasing hormone (GnRH) analogs, some anticonvulsant and psychotropic medications (excluding anti-depressant medication) and oral glucocorticoids)

•Use of skeletal muscle anabolic agents within the previous 3 months or during study participation (e.g., hormones such as growth hormone or testosterone, nutritional supplements (other than protein) and over-the-counter products labeled as muscle anabolic agents)

•Treatment with glucose-lowering agent(s) within 90 days before screening

•History of hypersensitivity to monoclonal antibodies or drugs in the same compound class as the study drugs

•History of fragility fracture or BMD T-score ≤ -2.5 in participants > 50 years old

•Use of IV bisphosphonates within the previous 2 years or other osteoporosis medications within the previous 12 months or during study participation

•Not able or willing to comply with dietary and lifestyle intervention for weight loss, including history of clinically significant condition that precludes regular walking for exercise or contraindication to following a 500-calorie daily deficit, high protein diet

•Women who are pregnant or breastfeeding

•Women of child-bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using an intrauterine device (IUD) from at least 3 months before the baseline visit through at least 4 months after the last drug dose and an additional contraceptive (barrier) method from screening through at least 4 months after the last drug dose. Women not of child-bearing potential are defined as individuals who (1) have a congenital anomaly such as Mullerian agenesis, resulting in confirmed infertility, (2) are infertile due to surgical sterilization (defined as documented hysterectomy, bilateral salpingo-oophorectomy, bilateral salpingectomy, or bilateral oophorectomy), or (3) are post-menopausal. The following groups of women are eligible to participate: (a) women who are s/p surgical bilateral oophorectomy or total hysterectomy at least 6 weeks before taking study treatment, (b) women who have an IUD (see additional criteria above), (c) women who are s/p tubal ligation provided that they use an additional barrier form of contraception from screening through at least 4 months after the last drug dose, (d) women who are post-menopausal defined as ≥12 months of spontaneous amenorrhea with appropriate clinical and hormonal profile (e.g., age-appropriate, history of vasomotor symptoms, and/or FSH >40 IU/L), (e) have a congenital anomaly resulting in confirmed infertility, and (f) do not have a history of sexual activity that could lead to pregnancy (i.e., total abstinence has been and is their preferred lifestyle or same-sex partners only).

•For men, morning serum testosterone less than 200 ng/dL

•Concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study

•Plans to move out of the study area within 16 months, or be out of the study area for >4 weeks, continuously

•Routine MRI exclusion

•Donation or loss of 400 mL or more of blood within past 2 months or plasma donation (> 250 mL) within past 2 weeks

•Major surgery in the trial period

•Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the subject's safety or compliance with the protocol

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

1 endpoint

Primary/protocol endpoint

Change in number of kilograms of lean mass by dual-energy x-ray absorptiometry

Time frame:52 weeks

Lean mass

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.