RCTNCT02972645Phase 1 · 2016 · n=66 · Eli Lilly and Company Pharmacokinetic / healthy volunteer studies
tested Number of Participants with One or More Serious Adverse Event(s) (SAEs) considered by the Investigator to be Related to Study Drug Administration
result Completed; results not posted
RCTNCT03325387Phase 1 · 2017 · n=56 · Eli Lilly and Company Pharmacokinetic / healthy volunteer studies
tested Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
result Completed; results not posted
RCTNCT03928379Phase 1 · 2019 · n=24 · Eli Lilly and Company Diabetes Mellitus, Type 2
tested Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
RCTNCT04440345Phase 1 · 2020 · n=60 · Innovent Biologics (Suzhou) Co. Ltd. Overweight or Obesity
tested Number of treatment adverse events
result Completed; results not posted
RCTNCT04466904Phase 1 · 2020 · n=42 · Innovent Biologics (Suzhou) Co. Ltd. Type 2 Diabetes
tested To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
result Completed; results not posted
RCTNCT04773977Phase 1 · 2021 · n=24 · Innovent Biologics (Suzhou) Co. Ltd. Overweight/Obesity
tested Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
RCTNCT04904913Phase 2 · 2021 · n=328 · Innovent Biologics (Suzhou) Co. Ltd. Overweight/ Obesity
tested Percent Change from Baseline in Body Weight
result Completed; results not posted
RCTNCT04965506Phase 2 · 2021 · n=252 · Innovent Biologics (Suzhou) Co. Ltd. Type 2 Diabetes
tested The change in HbA1c from baseline to 20 weeks
result Completed; results not posted
RCTNCT05606913Phase 3 · 2023 · n=731 · Innovent Biologics (Suzhou) Co. Ltd. Type 2 Diabetes
tested HbA1c change from baseline at week 28
result Completed; results not posted
RCTNCT05607680Phase 3 · 2022 · n=610 · Innovent Biologics (Suzhou) Co. Ltd. Obesity Or Overweight
tested Percent Change from Baseline in Body Weight
result Completed; results not posted
RCTNCT05623839Phase 1 · 2022 · n=32 · Eli Lilly and Company Overweight
tested Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
result Completed; results not posted
RCTNCT05628311Phase 3 · 2023 · n=319 · Innovent Biologics (Suzhou) Co. Ltd. Type 2 Diabetes
tested HbA1c change from baseline at week 24
result Completed; results not posted
RCTNCT06124807Phase 2 · 2023 · n=179 · Eli Lilly and Company Obesity
tested Percent Change From Baseline in Body Weight at Week 32
result −6.5 percent change (Percent Change From Baseline in Body Weight at Wee…)
RCTNCT06143956Phase 2 · 2023 · n=1481 · Eli Lilly and Company Obesity
tested Number of Participants Allocated to Each ISA
result In progress (recruiting)
RCTNCT06164873Phase 3 · 2023 · n=462 · Innovent Biologics (Suzhou) Co. Ltd. Obesity
tested Percent Change from Baseline in Body Weight
result In progress (active-not-recruiting)
RCTNCT06184568Phase 3 · 2024 · n=349 · Innovent Biologics (Suzhou) Co. Ltd. Type 2 Diabetes
tested Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss
result Completed; results not posted
RCTNCT06536023Phase 1 · 2024 · n=36 · Innovent Biologics (Suzhou) Co. Ltd. Adolescents With Obesity
tested Incidence of adverse events and serious adverse events
result Completed; results not posted
RCTNCT06817356Phase 2 · 2025 · n=308 · Eli Lilly and Company Alcohol Use Disorder
tested Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
result Completed; results not posted
RCTNCT06862908Phase 2 · 2025 · n=141 · Innovent Biologics (Suzhou) Co. Ltd. Obesity
tested Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
result In progress (recruiting)
RCTNCT06884293Phase 3 · 2025 · n=479 · Innovent Biologics (Suzhou) Co. Ltd. Overweight
tested percentage change in body weight from baseline
result In progress (active-not-recruiting)
RCTNCT06931028Phase 3 · 2025 · n=260 · Innovent Biologics (Suzhou) Co. Ltd. Sleep Apnea
tested Change from Baseline in Apnea-Hypopnea Index (AHI)
result In progress (recruiting)
RCTNCT06937749Phase 2 · 2025 · n=165 · Innovent Biologics (Suzhou) Co. Ltd. Metabolic Dysfunction-associated Steatohepatitis (MASH)
tested Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
result In progress (recruiting)
RCTNCT07000955Phase 1 · 2025 · n=98 · Innovent Biologics (Suzhou) Co. Ltd. Obesity
tested The Incidence of adverse events and serious adverse events during the treatment period
result In progress (active-not-recruiting)
RCTNCT07083154Phase 3 · 2025 · n=420 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Cognitive function in aging
tested Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change
result In progress (recruiting)
RCTNCT071351412025 · n=256 · Beijing Friendship Hospital Severe Obesity
tested the rate of excess weight loss(EWL%) compared to baseline
result In progress (recruiting)
RCTNCT07255209Phase 3 · 2025 · n=180 · Innovent Biologics (Suzhou) Co. Ltd. Adolescents With Obesity or Overweight With Weight-Related Comorbidities
tested Percent Change from Baseline in BMI
result In progress (recruiting)
RCTNCT07417306Phase 3 · 2026 · n=912 · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Type 2 Diabetes
tested Change from baseline in Hemoglobin A1c (HbA1c)
result In progress (recruiting)
RCTNCT07469800Phase 3 · 2026 · n=336 · Innovent Biologics (Suzhou) Co. Ltd. Overweight
tested To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment.
result In progress (recruiting)
RCTNCT075170422026 · n=420 · Shanghai Zhongshan Hospital Obesity
tested Percentage change of body weight
result In progress (recruiting)
RCTNCT07654062Phase 4 · 2026 · n=150 · Shandong Provincial Hospital Prediabetes
tested Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 24
result In progress (recruiting)
RCTNCT07657676Phase 4 · 2026 · n=116 · China National Center for Cardiovascular Diseases Obesity & Overweight
tested Change from baseline in total non-calcified plaque volume (NCPV) at 52 weeks measured by CCTA
result In progress (recruiting)
NAFLD / steatotic liver disease — hepatic fat reduction
tested Absolute change in liver fat content measured by MRI-PDFF
result In progress (recruiting)
RCTNCT07718126Phase 2 · 2026 · n=60 · West China Hospital Metabolic Dysfunction-Associated Steatohepatitis
tested Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM)
result In progress (recruiting)
Diabetes Mellitus, Type 2
tested Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44
result In progress (recruiting)
Treatment studies
tested Primary: safety/tolerability; secondary: % change in body weight, waist circumference, BMI
result 9 mg cohort: −11.7% BW vs −1.8% placebo at wk 12 (ETD −9.8%, P=0.0002); 10 mg cohort: −9.5% vs −3.3% at wk 16 (ETD −6.2%, P=0.0243); 50% achieved ≥10% weight loss in each IBI362 cohort
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Body weight change from baseline at week 12; safety and tolerability
result Weight change vs placebo (+0.60%): -4.81% (3.0 mg), -6.40% (4.5 mg), -6.05% (6.0 mg) at week 12. No discontinuations; no serious AEs.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Safety/tolerability (primary); HbA1c, FPG, post-MTT glucose (secondary)
result IBI362 well tolerated; HbA1c, FPG, post-MTT glucose reduced from baseline to week 12 across all 3 dose cohorts. Diarrhoea 29.2%, decreased appetite 25.0%, nausea 16.7%.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested body weight, waist circumference, BMI
result 9 mg: -11.7% body weight at wk 12 vs -1.8% placebo (ETD -9.8%, p=0.0002); 10 mg: -9.5% at wk 16 vs -3.3% placebo (ETD -6.2%, p=0.024)
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in HbA1c from baseline to week 20 (primary); body weight change (secondary)
result HbA1c −1.41% to −1.67% with mazdutide vs +0.03% placebo (all P<0.0001); body weight up to −7.1% vs −1.4% placebo at week 20.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Percentage change in body weight from baseline to week 24
result Body weight change: -6.7% (3 mg), -10.4% (4.5 mg), -11.3% (6 mg) vs +1.0% placebo; treatment difference -7.7% to -12.3% (all p<0.0001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested percentage change in body weight from baseline; proportion achieving ≥5% and ≥15% weight reduction at weeks 32 and 48
result Wk 48: -11.00% (4 mg) and -14.01% (6 mg) vs +0.30% placebo; ≥15% responders 35.7%/49.5% vs 2.0%; ≥5% responders 73.9%/82.0% vs 10.5% at wk 32. P<0.001 all.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested percent change in body weight, waist circumference, fasting metabolic biomarkers, appetite, safety
result Body weight -20.0% (Cohort 1) and -21.0% (Cohort 2) vs -0.1% placebo at Week 20 (p<0.001); ≥15% loss in 66.7%/75.0%; waist circumference -12.0%/-17.0% vs -0.8%.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested proportion achieving HbA1c target (primary); weight loss (secondary); 32-week active-controlled period + 24-week extension
result Design/baseline paper only — no efficacy results reported. First head-to-head RCT of mazdutide vs semaglutide in Chinese adults with T2D+obesity; expected completion early 2026.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested HbA1c change at week 24 (primary); body weight, composite glycaemic+weight response (secondary)
result HbA1c: -1.57% (4mg) and -2.15% (6mg) vs -0.14% placebo; treatment differences -1.43% and -2.02%; significant weight loss and composite endpoint (P<0.0006).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested HbA1c change from baseline at week 28; body weight change
result 4mg: HbA1c LS-mean diff −0.24% (P=0.0032), weight diff −3.78%; 6mg: HbA1c diff −0.30% (P=0.0003), weight diff −5.76% vs 1.5mg dulaglutide at 28 wk.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested percentage change in body weight from baseline at week 24
result Mazdutide 9 mg: -12.78% body weight vs +1.80% placebo; treatment difference -14.58% (95% CI -18.00, -11.16), p<0.001 at 24 weeks.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Percentage change in body weight from baseline; proportion achieving ≥5% weight reduction at week 60
result Mazdutide: -16.65% BW vs placebo -1.50% (difference -15.15%, P<.001); 84.3% vs 33.1% achieved ≥5% reduction (difference 51.6%, P<.001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
OpenNCT05793450Phase 1 · 2023 · n=20 · Innovent Biologics (Suzhou) Co. Ltd. Renal Impairment
tested Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05815680Phase 1 · 2023 · n=48 · Innovent Biologics (Suzhou) Co. Ltd. Overweight Subjects
tested Maximum observed metformin plasma concentration at steady state
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT06519656Phase 1 · 2024 · n=50 · Shanghai Zhongshan Hospital Polycystic Ovary Syndrome
tested Free Androgen Index (FAI)
result In progress (recruiting)
Non-randomised; effect size cannot be separated from placebo.
Treatment studies
tested weight, HbA1c, serum uric acid, lipid panel, hepatic steatosis (ultrasound)
result 36 wks: weight −16.8 kg (18.89% BMI reduction), HbA1c −21.88%, uric acid −37.00%, TG −69.02%, TC −13.65%, LDL −17.27%; steatosis resolved by wk 14.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested mouse · Multiparametric MRI Evaluation of Liver Fat and Iron after Glucagon-like Peptide-1 Receptor and Glucagon Receptor Dual-Agonist Treatment in a High-Fat Diet-induced Mouse Model.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.